Category: Device Advisories

FDA Advisory No. 2019-474 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “Shengde Digital Infrared Thermometer”

FDA Advisory No. 2019-474 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “Shengde Digital Infrared Thermometer”

The Food and Drug Administration (FDA) warns the general public against the purchase and use of the unregistered medical device:

  1. Shengde Digital Infrared Thermometer”

The FDA verified through post-marketing surveillance that the abovementioned medical device is not registered and the Certificate of Product Registration (CPR) has not yet been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unregistered medical device has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

In light of the foregoing, the public is advised not to purchase the violative product in the market.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device until CPR is issued, otherwise, regulatory actions and sanctions shall be strictly pursued.

All FDA Regional Field Offices and Regulatory Enforcement Units in coordination with law enforcement agencies and Local Government Units are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unregistered product.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8301.    

To report any sale or distribution of unregistered medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2019-474

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-474 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “Shengde Digital Infrared Thermometer”
FDA Advisory No. 2019-464 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Devices Advertised for sale in Lazada.com.ph

FDA Advisory No. 2019-464 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Devices Advertised for sale in Lazada.com.ph

The Food and Drug Administration (FDA) warns the general public and all healthcare professionals against the purchase and use of the unregistered medical devices advertised for sale in lazada.com.ph:

The FDA verified through post-marketing surveillance that the abovementioned medical devices are not registered and the Certificates of Product Registration (CPR) have not yet been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered medical devices have not gone through evaluation process of the FDA, the agency cannot assure their quality and safety.

In light of the foregoing, the public is advised not to purchase the violative products in the market.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical devices until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued.

All FDA Regional Field Offices and Regulatory Enforcement Units in coordination with law enforcement agencies and Local Government Units are requested to ensure that these products are not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of these unregistered products.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested

Attachment:-> FDA ADVISORY No. 2019-464

FDA Advisory No. 2019-462 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Devices “Pure-Aid Gauze Pads”

FDA Advisory No. 2019-462 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Devices “Pure-Aid Gauze Pads”

The Food and Drug Administration (FDA) warns the general public against the purchase and use of the unregistered medical device:

  1. “Pure-Aid Gauze Pads”

The FDA verified through post-marketing surveillance that the abovementioned medical device is not registered and the Certificate of Product Registration (CPR) has not yet been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unregistered medical device has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

In light of the foregoing, the public is advised not to purchase the violative product in the market.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device until CPR is issued, otherwise, regulatory actions and sanctions shall be strictly pursued.

All FDA Regional Field Offices and Regulatory Enforcement Units in coordination with law enforcement agencies and Local Government Units are requested to ensure that this product is not sold or made available in the market or their areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unregistered product.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA ADVISORY No. 2019-462

FDA Advisory No. 2019-461 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Devices “Natureplex Warm Touch Warming Jelly”

FDA Advisory No. 2019-461 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Devices “Natureplex Warm Touch Warming Jelly”

The Food and Drug Administration (FDA) warns the general public against the purchase and use of the unregistered medical device:

  1. “Natureplex Warm Touch Warming Jelly”

The FDA verified through post-marketing surveillance that the abovementioned medical device is not registered and the Certificate of Product Registration (CPR) has not yet been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unregistered medical device has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

In light of the foregoing, the public is advised not to purchase the violative product in the market.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device until CPR is issued, otherwise, regulatory actions and sanctions shall be strictly pursued.

All FDA Regional Field Offices and Regulatory Enforcement Units in coordination with law enforcement agencies and Local Government Units are requested to ensure that this product is not sold or made available in the market or their areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unregistered product.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8301.                                           

To report any sale or distribution of unregistered medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.]

Attachment:-> FDA ADVISORY No. 2019-461

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-461 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Devices “Natureplex Warm Touch Warming Jelly”
FDA Advisory No. 2019-460 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Devices “Dr. Sheffield’s Lubri-Gel Personal Lubricant Jelly”

FDA Advisory No. 2019-460 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Devices “Dr. Sheffield’s Lubri-Gel Personal Lubricant Jelly”

The Food and Drug Administration (FDA) warns the general public against the purchase and use of the unregistered medical device:

  1. “Dr. Sheffield’s Lubri-gel Personal Lubricant Jelly”

The FDA verified through post-marketing surveillance that the abovementioned medical device is not registered and the Certificate of Product Registration (CPR) has not yet been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unregistered medical device has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

In light of the foregoing, the public is advised not to purchase the violative product in the market.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device until CPR is issued, otherwise, regulatory actions and sanctions shall be strictly pursued.

All FDA Regional Field Offices and Regulatory Enforcement Units in coordination with law enforcement agencies and Local Government Units are requested to ensure that this product is not sold or made available in the market or their areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unregistered product.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8301.                

To report any sale or distribution of unregistered medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA ADVISORY No. 2019-460

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-460 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Devices “Dr. Sheffield’s Lubri-Gel Personal Lubricant Jelly”
FDA Advisory No. 2019-465 || Lifting the Advisory on the Following Registered Medical Devices under FDA Advisory No. 2019-342 and 2019-343 “Luxe Organix Hydrocolloid Acne Spot Patch Day Time and Luxe Organix Hydrocolloid Acne Spot Patch Night Time”

FDA Advisory No. 2019-465 || Lifting the Advisory on the Following Registered Medical Devices under FDA Advisory No. 2019-342 and 2019-343 “Luxe Organix Hydrocolloid Acne Spot Patch Day Time and Luxe Organix Hydrocolloid Acne Spot Patch Night Time”

The Food and Drug Administration (FDA) informs the public that the following medical devices have been registered by the Market Authorization Holder (MAH), Genson Distribution, Inc., in accordance to existing FDA rules and regulations.

1. Luxe Organix Hydrocolloid Acne Spot Patch Day Time, with Registration No. MDR-08696.
2. Luxe Organix Hydrocolloid Acne Spot Patch Night Time, with Registration No. MDR-08697. 

Accordingly, the warning against the purchase and use of the products as mentioned in FDA Advisory No. 2019-342 and 2019-343 is hereby lifted.

For more information and inquiries, kindly contact the FDA Center for Device Regulation. Radiation Health, and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device products, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

The issuance of this advisory shall not in any manner preclude this Office from issuing subsequent orders it may deem necessary and appropriate, should there be findings of any violation of the company to the existing laws, rules, and regulations.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA ADVISORY No. 2019-465

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-465 || Lifting the Advisory on the Following Registered Medical Devices under FDA Advisory No. 2019-342 and 2019-343 “Luxe Organix Hydrocolloid Acne Spot Patch Day Time and Luxe Organix Hydrocolloid Acne Spot Patch Night Time”
FDA Advisory No. 2019-463 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “DIGITAL THERMOMETER”

FDA Advisory No. 2019-463 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “DIGITAL THERMOMETER”

The Food and Drug Administration (FDA) warns the general public against the purchase and use of the unregistered medical device:

  1. “Digital Thermometer”

The FDA verified through post-marketing surveillance that the abovementioned medical device is not registered and the Certificate of Product Registration (CPR) has not yet been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unregistered medical device has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

In light of the foregoing, the public is advised not to purchase the violative product in the market.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device until CPR is issued, otherwise, regulatory actions and sanctions shall be strictly pursued.

All FDA Regional Field Offices and Regulatory Enforcement Units in coordination with law enforcement agencies and Local Government Units are requested to ensure that this product is not sold or made available in the market or their areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unregistered product.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8301.                                                                

To report any sale or distribution of unregistered medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA ADVISORY No. 2019-463

FDA Advisory No. 2019-393 || Voluntary Recall of BD Microtainer

FDA Advisory No. 2019-393 || Voluntary Recall of BD Microtainer

The Food and Drug Administration (FDA) warns all healthcare professionals on the voluntary recall of the following BD Microtainer® blood collection tubes manufactured by BD Caribe:

 

Product Name Product Code Lot Number
BD Microtainer® Capillary Blood Collection Tube with K2EDTA-Tube Micro w/ Microgard EDTA LAV 21041362 8243545
8247628
8288904
8121979
8120851
BD Microtainer® Z Capillary Blood Collection Tube  (No Additives)- Tube Micro w/ Microgard PLN RD 21041356 8223778
8268514
 

BD Microtainer® SST Capillary Blood Collection Tube-Tube Micro w/ Microgard SST GLD

 

 21041357 8170911
8282848
8165884
8117697
BD Microtainer® Amber Capillary Blood Collection Tube-Tube Micro w/ Microgard SST GLD/AMB 21041358 8233967

BD is conducting a voluntary recall for the aforementioned BD Microtainer® products based on the confirmation that these products may have damaged tube reservoirs.

A damaged reserviors may caused insufficient blood sample collection and non-proportional blood-to-additive ratio, hence producing inaccurate results. Moreover, a patient may be required to undergo a repeat blood sample collection and testing on the event that any of theaforementioned BD Microtainer® with damaged reservoir was used during blood collection.

In light of the foregoing, all concerned healthcare professionals, and establishments is warned to discontinue further use, sale, and distribution of the medical device.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that these health products are not sold or made available in the market or areas of jurisdiction.

To report any sale or distribution of unregistered medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Any suspected adverse reaction experienced from the use of the medical device but not limited to the lot numbers stated above should be reported immediately to FDA.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health, and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8301.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No. 2019-393

FDA Advisory No. 2019-390 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “INNOSPIRE MINI WITH SIDESTREAM PLUS”

FDA Advisory No. 2019-390 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “INNOSPIRE MINI WITH SIDESTREAM PLUS”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public against the purchase and use of the unregistered medical device:

  1. INNOSPIRE MINI WITH SIDESTREAM PLUS

The FDA verified through post-marketing surveillance that the abovementioned medical device is not registered and the Certificate of Product Registration (CPR) has not yet been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unregistered medical device has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

In light of the foregoing, the public is advised not to purchase the violative product in the market.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device until CPR is issued, otherwise, regulatory actions and sanctions shall be strictly pursued.

All FDA Regional Field Offices and Regulatory Enforcement Units in coordination with law enforcement agencies and Local Government Units are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unregistered product.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No. 2019-390

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-390 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “INNOSPIRE MINI WITH SIDESTREAM PLUS”
FDA Advisory No. 2019-389 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Antibacterial Patterned Bandages Plastic”

FDA Advisory No. 2019-389 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Antibacterial Patterned Bandages Plastic”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public against the purchase and use of the unregistered medical device:

  1. Antibacterial Patterned Bandages Plastic

he FDA verified through post-marketing surveillance that the abovementioned medical device is not registered and the Certificate of Product Registration (CPR) has not yet been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unregistered medical device has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

In light of the foregoing, the public is advised not to purchase the violative product in the market.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device until CPR is issued, otherwise, regulatory actions and sanctions shall be strictly pursued.

All FDA Regional Field Offices and Regulatory Enforcement Units in coordination with law enforcement agencies and Local Government Units are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unregistered product.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No. 2019-389

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-389 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Antibacterial Patterned Bandages Plastic”
FDA Advisory No. 2019-345 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Family Brand Absorbent Cotton”

FDA Advisory No. 2019-345 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Family Brand Absorbent Cotton”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public against the purchase and use of the unregistered medical device:

  1. Family Brand Absorbent Cotton

The FDA verified through post-marketing surveillance that the Certificate of Product Registration (CPR) of the abovementioned medical device has expired on 10 August 2017 hence, unregistered. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unregistered medical device has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

In light of the foregoing, the public is advised not to purchase the violative product in the market.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device until CPR is issued, otherwise, regulatory actions and sanctions shall be strictly pursued.

All FDA Regional Field Offices and Regulatory Enforcement Units in coordination with law enforcement agencies and Local Government Units are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unregistered product.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8301.                                                                 

To report any sale or distribution of unregistered medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No. 2019-345

FDA Advisory No. 2019-344 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Intersurgical Adult Nasal Cannula with Straight Prongs and Tube”

FDA Advisory No. 2019-344 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Intersurgical Adult Nasal Cannula with Straight Prongs and Tube”

The Food and Drug Administration (FDA) advises the general public and all healthcare professionals against the purchase and use of the unregistered medical device:

  1. Intersurgical Adult Nasal Cannula with Straight Prongs and Tube

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned medical device has not gone through the registration process of the agency and has not been issued with proper authorization in the form of Certificate of Product Registration (CPR).Pursuant to Republic Act 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from FDA is prohibited.

Accordingly, since this unregistered medical device have not gone through evaluation and testing process of the FDA, the agency cannot guarantee its quality and safety. The consumption of such violative product may pose potential health hazards to the consuming public.

In light of the above, the public is advised not to purchase the aforementioned violative products and to be vigilant against medical device that might not be duly registered with FDA. Always check if a medical device has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph.

All concerned establishments and/or entities are warned not to distribute the above-identified violative medical device products until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that this product is not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of the above unregistered medical device, utilize our online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail us via [email protected], or call us at the Center for Device Regulation, Radiation Health and Research (CDRRHR) hotline (02) 857-1900 local 8301.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA Advisory No. 2019-344

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-344 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Intersurgical Adult Nasal Cannula with Straight Prongs and Tube”
FDA Advisory No. 2019-343 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Luxe Organix Hydrocolloid Acne Spot Patch Night Time”

FDA Advisory No. 2019-343 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Luxe Organix Hydrocolloid Acne Spot Patch Night Time”

The Food and Drug Administration (FDA) advises the general public and all healthcare professionals against the purchase and use of the unregistered medical device:

  1. Luxe Organix Hydrocolloid Acne Spot Patch Night Time

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned medical device has not gone through the registration process of the agency and has not been issued with proper authorization in the form of Certificate of Product Registration (CPR).Pursuant to Republic Act 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from FDA is prohibited.

Accordingly, since this unregistered medical device have not gone through evaluation and testing process of the FDA, the agency cannot guarantee its quality and safety. The consumption of such violative product may pose potential health hazards to the consuming public.

In light of the above, the public is advised not to purchase the aforementioned violative products and to be vigilant against medical device that might not be duly registered with FDA. Always check if a medical device has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph.

All concerned establishments and/or entities are warned not to distribute the above-identified violative medical device products until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that this product is not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of the above unregistered medical device, utilize our online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail us via [email protected], or call us at the Center for Device Regulation, Radiation Health and Research (CDRRHR) hotline (02) 857-1900 local 8301.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA Advisory No. 2019-343

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-343 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Luxe Organix Hydrocolloid Acne Spot Patch Night Time”
FDA Advisory No. 2019-342 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Luxe Organix Hydrocolloid Acne Spot Patch Day Time”

FDA Advisory No. 2019-342 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Luxe Organix Hydrocolloid Acne Spot Patch Day Time”

The Food and Drug Administration (FDA) advises the general public and all healthcare professionals against the purchase and use of the unregistered medical device:

  1. Luxe Organix Hydrocolloid Acne Spot Patch Day Time

The FDA verified through post-marketing surveillance that the abovementioned medical device is not registered and the Certificate of Product Registration (CPR) has not yet been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unregistered medical device has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

In light of the foregoing, the public is advised not to purchase the violative product in the market.           

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device until CPR is issued, otherwise, regulatory actions and sanctions shall be strictly pursued.

All FDA Regional Field Offices and Regulatory Enforcement Units in coordination with law enforcement agencies and Local Government Units are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unregistered product.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No. 2019-342

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-342 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Luxe Organix Hydrocolloid Acne Spot Patch Day Time”
FDA Advisory No. 2019-341 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Devices “Waxvac Ear Cleaner”

FDA Advisory No. 2019-341 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Devices “Waxvac Ear Cleaner”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public against the purchase and use of the unregistered medical device:

  1. Waxvac Ear Cleaner

The FDA verified through post-marketing surveillance that the abovementioned medical device is not registered and the Certificate of Product Registration (CPR) has not yet been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unregistered medical device has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

In light of the foregoing, the public is advised not to purchase the violative product in the market.           

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device until CPR is issued, otherwise, regulatory actions and sanctions shall be strictly pursued.

All FDA Regional Field Offices and Regulatory Enforcement Units in coordination with law enforcement agencies and Local Government Units are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unregistered product.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No. 2019-341

FDA Advisory No. 2019-340 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Devices “Adhesive Bandages in foreign characters”

FDA Advisory No. 2019-340 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Devices “Adhesive Bandages in foreign characters”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public against the purchase and use of the unregistered medical device:

  1. Adhesive Bandages in foreign characters

The FDA verified through post-marketing surveillance that the abovementioned medical device is not registered and the Certificate of Product Registration (CPR) has not yet been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unregistered medical device has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

In light of the foregoing, the public is advised not to purchase the violative product in the market.           

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device until CPR is issued, otherwise, regulatory actions and sanctions shall be strictly pursued.

All FDA Regional Field Offices and Regulatory Enforcement Units in coordination with law enforcement agencies and Local Government Units are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unregistered product.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No. 2019-340

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-340 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Devices “Adhesive Bandages in foreign characters”
FDA Advisory No. 2019-338 || Public Health Warning Against the Purchase and Use of the following Unregistered Medical Devices:

FDA Advisory No. 2019-338 || Public Health Warning Against the Purchase and Use of the following Unregistered Medical Devices:

The Food and Drug Administration (FDA) warns the general public and all healthcare professionals against the purchase and use of the unregistered medical devices:

  1. Daiso – Fruit Fragrance Bandages
  2. Daiso – Cold Wrap – Icing Relief Stretch Bandage

The FDA verified through post-marketing surveillance that the abovementioned medical device is not registered and the Certificate of Product Registration (CPR) has not yet been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unregistered medical device has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

In light of the foregoing, the public is advised not to purchase the violative product in the market.           

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device until CPR is issued, otherwise, regulatory actions and sanctions shall be strictly pursued.

All FDA Regional Field Offices and Regulatory Enforcement Units in coordination with law enforcement agencies and Local Government Units are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unregistered product.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No. 2019-338

FDA Advisory No. 2019-337 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “OU 40 SPORT BANDAGES”

FDA Advisory No. 2019-337 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “OU 40 SPORT BANDAGES”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public against the purchase and use of the unregistered medical device:

  1. OU 40 SPORT BANDAGES

The FDA verified through post-marketing surveillance that the abovementioned medical device is not registered and the Certificate of Product Registration (CPR) has not yet been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unregistered medical device has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

In light of the foregoing, the public is advised not to purchase the violative product in the market.           

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device until CPR is issued, otherwise, regulatory actions and sanctions shall be strictly pursued.

All FDA Regional Field Offices and Regulatory Enforcement Units in coordination with law enforcement agencies and Local Government Units are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unregistered product.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No. 2019-337

FDA Advisory No. 2019-336 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Unimex Gauze Swab”

FDA Advisory No. 2019-336 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Unimex Gauze Swab”

The Food and Drug Administration (FDA) warns all concerned healthcare professionals and the public against the purchase and use of the unregistered medical device:

  1. Unimex Gauze Swab

The FDA verified through post-marketing surveillance that the abovementioned medical device is not registered and the Certificate of Product Registration (CPR) has not yet been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unregistered medical device has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

In light of the foregoing, the public is advised not to purchase the violative product in the market.           

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device until CPR is issued, otherwise, regulatory actions and sanctions shall be strictly pursued.

All FDA Regional Field Offices and Regulatory Enforcement Units in coordination with law enforcement agencies and Local Government Units are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unregistered product.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No. 2019-336

FDA Advisory No. 2019-335 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Steadlive Anti Regurgitation Drainage Bag-Medical Urine Collection Bag”

FDA Advisory No. 2019-335 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Steadlive Anti Regurgitation Drainage Bag-Medical Urine Collection Bag”

The Food and Drug Administration (FDA) warns all concerned healthcare professionals and the public against the purchase and use of the unregistered medical device:

  1. Steadlive Anti Regurgitation Drainage Bag-Medical Urine Collection Bag

The FDA verified through post-marketing surveillance that the abovementioned medical device is not registered and the Certificate of Product Registration (CPR) has not yet been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unregistered medical device has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

In light of the foregoing, the public is advised not to purchase the violative product in the market.           

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device until CPR is issued, otherwise, regulatory actions and sanctions shall be strictly pursued.

All FDA Regional Field Offices and Regulatory Enforcement Units in coordination with law enforcement agencies and Local Government Units are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unregistered product.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No. 2019-335

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-335 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Steadlive Anti Regurgitation Drainage Bag-Medical Urine Collection Bag”
FDA Advisory No. 2019-334 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “HCG Test Strip”

FDA Advisory No. 2019-334 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “HCG Test Strip”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public against the purchase and use of the unregistered medical device:

  1. HCG Test Strip

The FDA verified through post-marketing surveillance that the abovementioned medical device is not registered and the Certificate of Product Registration (CPR) has not yet been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unregistered medical device has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

In light of the foregoing, the public is advised not to purchase the violative product in the market.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device until CPR is issued, otherwise, regulatory actions and sanctions shall be strictly pursued.

All FDA Regional Field Offices and Regulatory Enforcement Units in coordination with law enforcement agencies and Local Government Units are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unregistered product.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No. 2019-334

 

FDA Advisory No. 2019-333 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “I-Shield Gauze Bandage 3″ x 10 yards”

FDA Advisory No. 2019-333 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “I-Shield Gauze Bandage 3″ x 10 yards”

The Food and Drug Administration (FDA) warns all concerned healthcare professionals and the public against the purchase and use of the unregistered medical device:

  1. I-Shield Gauze Bandage 3″ x 10 yards

The FDA verified through post-marketing surveillance that the abovementioned medical device is not registered and the Certificate of Product Registration (CPR) has not yet been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unregistered medical device has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

In light of the foregoing, the public is advised not to purchase the violative product in the market.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device until CPR is issued, otherwise, regulatory actions and sanctions shall be strictly pursued.

All FDA Regional Field Offices and Regulatory Enforcement Units in coordination with law enforcement agencies and Local Government Units are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unregistered product.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No. 2019-333

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-333 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “I-Shield Gauze Bandage 3″ x 10 yards”
FDA Advisory No. 2019-332 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Assured Gauze Pads Compresses”

FDA Advisory No. 2019-332 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Assured Gauze Pads Compresses”

The Food and Drug Administration (FDA) warns all concerned healthcare professionals and the public against the purchase and use of the unregistered medical device:

  1. Assured Gauze Pads Compresses

The FDA verified through post-marketing surveillance that the abovementioned medical device is not registered and the Certificate of Product Registration (CPR) has not yet been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unregistered medical device has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

In light of the foregoing, the public is advised not to purchase the violative product in the market.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device until CPR is issued, otherwise, regulatory actions and sanctions shall be strictly pursued.

All FDA Regional Field Offices and Regulatory Enforcement Units in coordination with law enforcement agencies and Local Government Units are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unregistered product.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No. 2019-332

FDA Advisory No. 2019-331 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “Obon Natural Rubber Latex Male Condoms”

FDA Advisory No. 2019-331 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “Obon Natural Rubber Latex Male Condoms”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public against the purchase and use of the unregistered medical device:

  1. Obon Natural Rubber Latex Male Condoms

The FDA verified through post-marketing surveillance that the abovementioned medical device is not registered and the Certificate of Product Registration (CPR) has not yet been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unregistered medical device has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

In light of the foregoing, the public is advised not to purchase the violative product in the market.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device until CPR is issued, otherwise, regulatory actions and sanctions shall be strictly pursued.

All FDA Regional Field Offices and Regulatory Enforcement Units in coordination with law enforcement agencies and Local Government Units are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unregistered product.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No. 2019-331

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-331 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “Obon Natural Rubber Latex Male Condoms”
FDA Advisory No. 2019-330 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “1Pair Left+Right Bandage Orthopedic Hand Brace Wrist Support Finger Splint Carpal Tunnel Syndrom”

FDA Advisory No. 2019-330 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “1Pair Left+Right Bandage Orthopedic Hand Brace Wrist Support Finger Splint Carpal Tunnel Syndrom”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public against the purchase and use of the unregistered medical device:

  1. 1Pair Left+Right Bandage Orthopedic Hand Brace Wrist Support Finger Splint Carpal Tunnel Syndrom

The FDA verified through post-marketing surveillance that the abovementioned medical device is not registered and the Certificate of Product Registration (CPR) has not yet been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unregistered medical device has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

In light of the foregoing, the public is advised not to purchase the violative product in the market.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device until CPR is issued, otherwise, regulatory actions and sanctions shall be strictly pursued.

All FDA Regional Field Offices and Regulatory Enforcement Units in coordination with law enforcement agencies and Local Government Units are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unregistered product.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No. 2019-330

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-330 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “1Pair Left+Right Bandage Orthopedic Hand Brace Wrist Support Finger Splint Carpal Tunnel Syndrom”
FDA Advisory No. 2019-309 || RADIATION PROTECTION TRAINING CERTIFICATE REQUIREMENT OF THE CENTER FOR DEVICE REGULATION, RADIATION HEALTH AND RESEARCH (CDRRHR)

FDA Advisory No. 2019-309 || RADIATION PROTECTION TRAINING CERTIFICATE REQUIREMENT OF THE CENTER FOR DEVICE REGULATION, RADIATION HEALTH AND RESEARCH (CDRRHR)

This is in connection with the Radiation Protection Officer (RPO) training certificate as one of the documentary requirements to be submitted by an applicant to FDA-CDRRHR in relation to the License to Operate (LTO) as radiation facility or establishment.

For clarification, please be informed that the FDA CDRRHR or the FDA Academy does not offer or conduct radiation protection training for Radiation Protection Officers. However, the FDA-CDRRHR accepts training certificates, certifications, proof of completion or participation on the said topic that are issued by a third party service provider from the sectors of the industry, academe, government or National Regulatory Authority, or non-government organization (NGO) both here and abroad that is recognized, certified or accredited by the Philippine Accreditation Board, Professional Regulatory Commission, ISO Certification bodies, Commission on Higher Education, professional or industry organizations, and other relevant international organizations, like the International Atomic Energy Agency.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health, and Research (CDRRHR) through e-mail at [email protected] and cc: the Policy and Planning Service-FDA Academy at [email protected].

Dissemination of this advisory by all concerned parties and stakeholders is hereby requested.

Attachment: > FDA Advisory No. 2019-309

FDA Advisory No. 2019-308 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “INFECTIGUARD KID’S STERILE BANDAGES”

FDA Advisory No. 2019-308 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “INFECTIGUARD KID’S STERILE BANDAGES”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public against the purchase and use of the unregistered medical device:

1. INFECTIGUARD KID’S STERILE BANDAGES

The FDA verified through post-marketing surveillance that the abovementioned medical device, is not registered and the Certificate of Product Registration (CPR) has not yet been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unregistered medical device has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

In light of the foregoing, the public is advised not to purchase the violative product in the market.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device until CPR is issued, otherwise, regulatory actions and sanctions shall be strictly pursued.

All FDA Regional Field Offices and Regulatory Enforcement Units in coordination with law enforcement agencies and Local Government Units are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unregistered product.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment-> : FDA Advisory No. 2019-308

FDA Advisory No. 2019-307 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “DELCARE – STOMACH TUBE”

FDA Advisory No. 2019-307 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “DELCARE – STOMACH TUBE”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public against the purchase and use of the unregistered medical device:
 
1. DELCARE – STOMACH TUBE

The FDA verified through post-marketing surveillance that the abovementioned medical device, is not registered and the Certificate of Product Registration (CPR) has not yet been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unregistered medical device has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

In light of the foregoing, the public is advised not to purchase the violative product in the market.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device until CPR is issued, otherwise, regulatory actions and sanctions shall be strictly pursued.

All FDA Regional Field Offices and Regulatory Enforcement Units in coordination with law enforcement agencies and Local Government Units are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unregistered product.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment-> : FDA Advisory No. 2019-307

FDA Advisory No. 2019-306 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “Langhe Disposable Circumcision Suture Device”

FDA Advisory No. 2019-306 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “Langhe Disposable Circumcision Suture Device”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public against the purchase and use of the unregistered medical device:

  1. Langhe Disposable Circumcision Suture Device

The FDA verified through post-marketing surveillance that the abovementioned medical device, advertised for sale on www.lazada.com.ph, is not registered and the Certificate of Product Registration (CPR) has not yet been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unregistered medical device has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

In light of the foregoing, the public is advised not to purchase the violative product in the market.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device until CPR is issued, otherwise, regulatory actions and sanctions shall be strictly pursued.

All FDA Regional Field Offices and Regulatory Enforcement Units in coordination with law enforcement agencies and Local Government Units are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unregistered product.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment-> : FDA Advisory No. 2019-306

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-306 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “Langhe Disposable Circumcision Suture Device”
FDA Advisory No. 2019-287 || Public Health Warning Against the Purchase and Use of the following Unregistered Snibe Diagnostic Maglumi Medical Devices:

FDA Advisory No. 2019-287 || Public Health Warning Against the Purchase and Use of the following Unregistered Snibe Diagnostic Maglumi Medical Devices:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public against the purchase and use of the unregistered medical devices:

1. Syphilis
2. HBsAg
3. Anti-HBs
4. HIV Ab/Ag Combi
5. Anti-HCV

to continue reading, click the attachment below…

Attachment-> : FDA Advisory No. 2019-287