Category: Device Advisories

FDA Advisory No. 2019-214 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “ETHICON” HOSPITAL PACK CHROMIC STERILE CATGUT SUTURE”

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.  “ETHICON” HOSPITAL PACK CHROMIC STERILE CATGUT SUTURE”

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.

Furthermore, the FDA, in coordination with Johnson & Johnson (Philippines), Inc. verified that the above-stated medical device product is not part of their registered portfolio and there is no transaction history of the product concerned.

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) 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.2019-214

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-214 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “ETHICON” HOSPITAL PACK CHROMIC STERILE CATGUT SUTURE”

FDA Advisory No. 2018-297-A || Termination of the Voluntary Product Recall of the following medical device products:

This is to inform the public and concerned healthcare professionals that the Voluntary recall order issued on specific batch/es of Novosyn® Violet Dyed Suture with Needle and Safil® Violet Surgical Suture as shown in the table below is hereby terminated by the Food and Drug Administration (FDA).

Article Number Article Name Batch
C0068029 Novosyn® Violet 4/0 (1.5) 70cm HR22 (M) 718043
718042
718064
C0068595 Novosyn® Violet 2/0 (3) 90cm HR 37S (M) 717526
717525
C1048540 Safil® Violet 4/0 (1.5) 90cm HR 26 (M) 717445

 

As stated in the FDA Advisory No. 2018-297 dated 05 October 2018, B. Braun Medical Supplies, the Marketing Authorization Holder (MAH), conducted a voluntary recall of the above-stated medical device products as a Field Safety Corrective Action in response to the report received from the manufacturer. In the course of routine quality audits at the production site, the manufacturer detected that some units of the abovementioned batches have damaged packaging, which may have compromised the sterility of the product.

After due and thorough evaluation of the submitted documents by the MAH, FDA has determined that reasonable efforts had been made to recall and properly destroy the affected product batch in accordance with FDA Circular No. 2016-012, known as the Guidelines on Product Recall.

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 subsequent findings of any violation of existing FDA laws, rules and regulations.

All FDA Regional Field Offices and Regulatory Enforcement Units in coordination with law enforcement agencies and Local Government Units are requested to monitor and seize the cited product batches if still found available in the market.

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.2018-297-A

FDA Advisory No. 2019-198 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “MEDICLEAN ELASTIC BANDAGE”

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. Mediclean Elastic Bandage

The FDA verified through post-marketing surveillance that the abovementioned medical device are 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 from FDA is prohibited.

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

In light of the foregoing, the public is hereby advised not to purchase this 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 Field Officers and Regulatory Enforcement Unit in coordination with law enforcement agencies and Local Government Unit are requested to ensure that this product is not sold or made available in their localities or areas or jurisdiction.

The Bureau of Customs is urged to retrain 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.2019-198

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-198 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “MEDICLEAN ELASTIC BANDAGE”

FDA Advisory No. 2019-197 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “Family Care Bandage”:

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. Family Care Bandage

The FDA verified through post-marketing surveillance that the abovementioned medical device are not registered and the Certificate 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 from FDA is prohibited.

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

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

All concerned establishments are warned not to distribute the above-identified violative medical device until the Certificate of Product Registration is issued, otherwise, regulatory actions and sanctions shall be strictly pursued.

All FDA Field Officers and Regulatory Enforcement Unit in coordination with law enforcement agencies and Local Government Unit are requested to ensure that this product is not sold or made available in their localities or areas or jurisdiction.

The Bureau of Customs is urged to retrain 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.2019-197

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-197 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “Family Care Bandage”:

FDA Advisory No. 2019-196 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Coralite Bandage with Non-Stick Pad”

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. Coralite Bandage with Non-Stick Pad

The FDA verified through post-marketing surveillance that the abovementioned medical device are 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 from FDA is prohibited.

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

In light of the foregoing, the public is hereby advised not to purchase this 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 Field Officers and Regulatory Enforcement Unit in coordination with law enforcement agencies and Local Government Unit are requested to ensure that this product is not sold or made available in their localities or areas or jurisdiction.

The Bureau of Customs is urged to retrain 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.2019-196

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-196 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Coralite Bandage with Non-Stick Pad”

FDA Advisory No. 2019-195 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “DUNHAME NEBULIZER MASK WITH CHAMBER AND TUBING”

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. DUNHAME NEBULIZER MASK WITH CHAMBER AND TUBING

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) 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.2019-195

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-195 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “DUNHAME NEBULIZER MASK WITH CHAMBER AND TUBING”

FDA Advisory No. 2019-194 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “SECURE NASAL OXYGEN CANNULA CHILD”

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. Secure Nasal Oxygen Cannula Child

The FDA verified through post-marketing surveillance that the abovementioned medical device is not registered and the Certificate of Product Registration (CPR) has not been issued. 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 any health product without the proper authorization is prohibited.

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

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

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

All FDA Field Officers and Regulatory Enforcement Unit in coordination with the law enforcement agencies and Local Government Units are requested to ensure that this product is not sold or made available in their localities 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 email at [email protected] or call (02) 857-1900 local 8301.

To report any sale or distribution of the above 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.2019-194

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-194 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “SECURE NASAL OXYGEN CANNULA CHILD”

FDA Advisory No. 2019-193 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device:Arturo Fixotherm SP-FT-001 Digital Fever Thermometer,advertised for sale in Shopee website

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

  1. Arturo Fixotherm SP-FT-001 Digital Fever 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 been issued. 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 any health product without the proper authorization is prohibited.

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

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

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

All FDA Field Officers and Regulatory Enforcement Unit in coordination with the law enforcement agencies and Local Government Units are requested to ensure that this product is not sold or made available in their localities 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 email at [email protected] or call (02) 857-1900 local 8301.

To report any sale or distribution of the above 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.2019-193

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-193 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device:Arturo Fixotherm SP-FT-001 Digital Fever Thermometer,advertised for sale in Shopee website

FDA Advisory No. 2019-192 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “UNIMEX® LATEX DISPOSABLE GLOVES”

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. Unimex® Latex Disposable Gloves

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) 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.2019-192

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-192 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “UNIMEX® LATEX DISPOSABLE GLOVES”

FDA Advisory No. 2019-191 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “SUPERMED SUCTION CATHETER”

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. Supermed Suction Catheter

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) 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.2019-191

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-191 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “SUPERMED SUCTION CATHETER”

FDA Advisory No. 2019-178 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device: BFP™ Ovulation & Pregnancy Test Strips for Trying- To-Conceive Woman

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

  1. BFP™ Ovulation & Pregnancy Test Strips for Trying- To-Conceive Woman

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 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 are 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 hereby advised not to purchase this violative product in the market.

All concerned establishments are warned not to distribute violative medical device until it has been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the medical device.

All FDA Field Officers and Regulatory Enforcement Unit (REU) in coordination with the law enforcement agencies and Local Government Units (LGUs) are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

Kindly contact the FDA Center for Device Regulation, Radiation Health and Research through e-mail at [email protected], or call (02) 857-1900 local 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.

FDA Advisory No.2019-178

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-178 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device: BFP™ Ovulation & Pregnancy Test Strips for Trying- To-Conceive Woman

FDA Advisory No. 2019-177 || Public Health Warning Against the Purchase and Use of the following Unregistered Medical Devices:

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

  1. Smileplus Bandage Children’s Cartoon
  2. Smileplus Bandage Children’s Colored for Kids

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 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 are prohibited.

Since this unregistered medical device has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety. The use of such violative product may pose potential health hazard to the consuming public.

In light of the above, the public is advised not to purchase this product in the market. Moreover, the public is advised to always check if a medical device is registered with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing-in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative medical device until it has been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the medical device.

All FDA Field Officers and Regulatory Enforcement Unit (REU) in coordination with the law enforcement agencies and Local Government Units (LGUs) are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

Kindly contact the FDA Center for Device Regulation, Radiation Health and Research through e-mail at [email protected], or call (02) 857-1900 local 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.

FDA Advisory No.2019-177

FDA Advisory No. 2019-176 || Public Health Warning Against the Purchase and Use of Unregistered Medical Devices:

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

  1. Add Gray Contact Lens
  2. GBT Contact Lens
  3. G&G SI Soft Contact Lens
  4. G&G SII Soft Contact Lens
  5. CQ Plus Soft Contact Lens
  6. K-Luv Soft Contact Lens
  7. Skinny Magic-eye Premium Contact Lens

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 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 are prohibited.

Since this unregistered medical device has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety. The use of such violative product may pose potential health hazard to the consuming public.

In light of the above, the public is advised not to purchase this product in the market. Moreover, the public is advised to always check if a medical device is registered with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing-in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative medical device until it has been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the medical device.

All FDA Field Officers and Regulatory Enforcement Unit (REU) in coordination with the law enforcement agencies and Local Government Units (LGUs) are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

Kindly contact the FDA Center for Device Regulation, Radiation Health and Research through e-mail at [email protected], or call (02) 857-1900 local 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.

FDA Advisory No.2019-176

FDA Advisory No. 2019-175 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device: Sejoy® Cute Animals Diagnostic Digital Monitor Thermometer Oxter, advertised for sale on Shopee website

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

  1. Sejoy® Cute Animals Diagnostic Digital Monitor Thermometer Oxter

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 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 are prohibited.

Since this unregistered medical device has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety. The use of such violative product may pose potential health hazard to the consuming public.

In light of the above, the public is advised not to purchase this product in the market. Moreover, the public is advised to always check if a medical device is registered with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing-in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative medical device until it has been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the medical device.

All FDA Field Officers and Regulatory Enforcement Unit (REU) in coordination with the law enforcement agencies and Local Government Units (LGUs) are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

Kindly contact the FDA Center for Device Regulation, Radiation Health and Research through e-mail at [email protected], or call (02) 857-1900 local 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.

FDA Advisory No.2019-175

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-175 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device: Sejoy® Cute Animals Diagnostic Digital Monitor Thermometer Oxter, advertised for sale on Shopee website

FDA Advisory No. 2019-174 || Public Health Warning Against the Purchase and Consumption of the Unregistered Medical Device Hydroxypropyl Methylcellulose Ophthalmic Solution USP 2% w/v

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. Hydroxypropyl Methylcellulose Ophthalmic Solution USP 2% w/v

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 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 are prohibited.

Since this unregistered medical device has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety. The use of such violative product may pose potential health hazard to the consuming public.

In light of the above, the public is advised not to purchase this product in the market. Moreover, the public is advised to always check if a medical device is registered with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing-in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative medical device until it has been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the medical device.

All FDA Field Officers and Regulatory Enforcement Unit (REU) in coordination with the law enforcement agencies and Local Government Units (LGUs) are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

Kindly contact the FDA Center for Device Regulation, Radiation Health and Research through e-mail at [email protected], or call (02) 857-1900 local 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.

FDA Advisory No.2019-174

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-174 || Public Health Warning Against the Purchase and Consumption of the Unregistered Medical Device Hydroxypropyl Methylcellulose Ophthalmic Solution USP 2% w/v

FDA Advisory No. 2019-115 || Public Health Warning Against the Purchase and Use of Unregistered Health Related Device (Water Purification Device) “Wellohas Active Hydrogen Alkaline Water System”

The Food and Drug Administration (FDA) advises the public against the purchase and use of the unregistered health related device Wellohas Active Hydrogen Alkaline Water System:

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned health related device has not gone through the registration process of the agency and has not been issued the proper authorization in the form of Certificate of Health Related Device Registration (CHRDR). 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 health related device has 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. Water purification device/system should not bear any false, deceptive and misleading claims and promotional ploys on alkaline water, oxygenated water or ionized water.

Furthermore, the FDA has already issued two advisory (FDA Advisory Numbers 2011-013 and 2014-010) warning the general public against false, deceptive and misleading non-certified therapeutic claims and promotional ploys of water purification devices producing water labeled as alkaline, ionized, pi, oxygenated or energized water.

In light of the above, the public is advised not to purchase the aforementioned violative product and to be vigilant against health related device that might not be duly registered with FDA. Always check if a health related 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 health related device until it has 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 health related device, utilize our online reporting facility, Report, 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.

FDA Advisory No. 2019-115

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FDA Advisory No. 2019-136 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Yongrow Medical Infrared Forehead baby Thermometer” advertised for sale in Shopee website

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. Yongrow Medical Infrared Forehead baby Thermometer

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 has 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 this 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 devices product until he has 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 ofjurisdiction.

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.

FDA Advisory No. 2019-136

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-136 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Yongrow Medical Infrared Forehead baby Thermometer” advertised for sale in Shopee website

FDA Advisory No. 2019-137 || Public Health Warning Against the Purchase and Use of Surgitech Hypo-Allergenic Surgical Gloves (Powder Free)

The Food and Drug Administration (FDA) advises all concerned healthcare professionals and the public against the purchase and use of Surgitech Hypo-Allergenic Surgical Gloves (Powder Free)

FDA post-marketing surveillance activities have verified that Surgitech Hypo-Allergenic Surgical Gloves (Powder Free) has not gone through the registration process of the agency and has not been issued with Certificate of Product Registration (CPR).

Pursuant to the provisions of 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 any health product without the proper authorization are prohibited.

Since the abovementioned product did not undergo the evaluation process of the FDA, the agency cannot guarantee its quality and safety.

In this regard, the public is hereby advised not to purchase the above-mentioned violative product. All concerned establishments are warned not to advertise, sell or distribute the said product until such has been issued with the corresponding Certificate of Product Registration, 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 ofjurisdiction.

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

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2019-137

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FDA Advisory No. 2019-135 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “First + Aid Plastic Bandage Transparent 72 x 19mm Sterile Breathable Waterproof”

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. First + Aid Plastic Bandage Transparent 72 x 19mm Sterile Breathable Waterproof

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 has 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 ofthe above, the public is advised not to purchase this 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 devices product until he has 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 ofjurisdiction.

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.

FDA Advisory No. 2019-135

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-135 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “First + Aid Plastic Bandage Transparent 72 x 19mm Sterile Breathable Waterproof”

FDA Advisory No. 2019-134 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Pharmaline Monitor Infrared Thermometer” advertised for sale in Shopee website

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. Pharmaline Monitor Infrared Thermometer

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 has 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 this 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 devices product until he has 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 ofjurisdiction.

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.

FDA Advisory No. 2019-134

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-134 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Pharmaline Monitor Infrared Thermometer” advertised for sale in Shopee website

FDA Advisory No. 2019-133 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device — Climaxxx™ Stimulating Gel and Lubricant

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

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned medical device product 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. Pursuant to 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 from FDA is prohibited.

Accordingly, since this unregistered medical device has not gone through evaluation and testing process of the FDA, the agency cannot guarantee its quality and safety.

In light of the above, the public is advised not to purchase the aforementioned violative product 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 product until it has 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 or jurisdiction.

For more information and inquiries, please email 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 loc. 8301.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2019-133

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-133 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device — Climaxxx™ Stimulating Gel and Lubricant

FDA Advisory No. 2019-132 || Public Health Warning Against the Purchase and Use of Unregistered Health Related Devices Advertised for sale in Lazada.com.ph:

The Food and Drug Administration (FDA) advises the general public against the purchase and use of the following unregistered health related device products.

  1. High Quality 3 in 1 Alkaline Water Purifier Complete Set
  2. Central Nanyang 5-Stage Reverse Osmosis Water Filtration System Ultra Safe with Tank and Pump
  3. Global 3 in 1 Water Purifier
  4. Netwire Direct Alkaline Water Purifier with Ultraviolet Lamp
  5. Semter Sink Alkaline Water Purifier
  6. Premium 5 Stage Under Sink Water Filter System Drinking Home RO Membrane Purifier

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned health related device products have not gone through the registration process of the agency and have not been issued with the proper authorization in the form of Certificate of Health Related Device Registration (CHRDR). Pursuant to 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 from FDA is prohibited.

Accordingly, since this unregistered health related device products 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. Health related device products especially water purification device/ system shall not bear any false, deceptive and misleading claims and promotional ploys on alkaline water, oxygenated water or ionized water (Please see FDA Advisory Nos. 2014-010-A, 2014-010 and 2011-013).

In light of the above, the public is advised not to purchase the aforementioned violative products. Moreover, the public is advised to be vigilant against health related device products that might not be duly registered with FDA. Always check if a health related device product has been registered with 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 are warned not to distribute the above-identified violative health related device product until it has 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 localities or areas or jurisdiction.

For more information and inquiries, please e-mail us at [email protected] To report continuous sale or distribution of the above unregistered health related device product, utilize our online reporting facility, eReport, at www.fda.gov.ph/ereport, or email 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. 2019-132

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-132 || Public Health Warning Against the Purchase and Use of Unregistered Health Related Devices Advertised for sale in Lazada.com.ph:

FDA Advisory No. 2018-236 Public Health Warning Against the Purchase and Use of Unregistered Medical Devices (Weckstat Skin Staple Remover and Weck Visistat 35W Disposable Skin Stapler with 35 Wide Staples)

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

FDA post-marketing surveillance activities have verified that Weckstat Skin Staple Remover (see Figure 1) and Weck Visistat 35W Disposable Skin Stapler with 35 Wide Staples (see Figure 2) have not gone through the registration process of the agency and have not been issued with Certificate of Product Registration (CPR).

Pursuant to the provisions of  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 any health product without the proper authorization are prohibited.

Since the abovementioned products did not undergo the evaluation process of the FDA, the agency cannot guarantee their quality and safety.

In this regard, the public is hereby advised not to purchase the above-mentioned violative products. All concerned establishments are warned not to advertise, sell or distribute the said products until such have been issued with the corresponding Certificate of Product Registration, otherwise, regulatory actions and sanctions shall be strictly pursued.

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

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

Dissemination of the information to all concerned is requested.

 

 

/ In Device Advisories / By FDA_Admin2 / Comments Off on FDA Advisory No. 2018-236 Public Health Warning Against the Purchase and Use of Unregistered Medical Devices (Weckstat Skin Staple Remover and Weck Visistat 35W Disposable Skin Stapler with 35 Wide Staples)
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