Category: Device Advisories

FDA Advisory No. 2019-110-A || Lifting the Advisory on the Following Registered Medical Devices under FDA Advisory No. 2019 -110 “HR™ Lubricating Jelly One Shot”

The Food and Drug Administration (FDA) informs the public that the HR™ Lubricating Jelly One Shot has been registered by the Market Authorization Holder (MAH), Berovan Marketing Inc., with FDA registration number MDR-06020A in accordance to existing FDA rules and regulations.

Accordingly, the warning against the purchase and use of the product as mentioned in FDA Advisory No. 2019-110 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. 2019-110-A

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-110-A || Lifting the Advisory on the Following Registered Medical Devices under FDA Advisory No. 2019 -110 “HR™ Lubricating Jelly One Shot”

FDA Advisory No. 2019-247 || 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. Ximivogue Germicidal Breathable Band-Aid Set
  2. Ximivogue Band-Aid Cartoon

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. 2019-247

FDA Advisory No. 2019-246 || Public Health Warning Against False, Deceptive and Misleading Health Claims of Pantyliners/Sanitary Napkins

Reiteration of the issuance of FDA Advisory No. 2017-323 regarding the false, deceptive and misleading health claims of pantyliners/sanitary napkins.

The Food and Drug Administration (FDA) reissues this advisory to inform the general public the proliferation of pantyliners/sanitary napkins with health claims e.g. relieves tension, reduces irritation, prevents/cures diseases/infection such as UTI, Myoma, vaginal odor, hormonal imbalance etc., and releases negative ions.

While as general rule, pantyliners/sanitary napkins are not required to seek proper authorization from the FDA, pantyliners/sanitary napkins with health claims, require such authorization. The sale/marketing of such unregistered product constitutes violation of Section 10 of Republic Act No. 9711 otherwise known as the “Food and Drug Administration Act of 2009”.

On the other hand, the false, deceptive and misleading advertisement of these pantyliners/ sanitary napkins, constitutes violation of Title III, Chapter I of Republic Act No. 7394, otherwise known as the “Consumer Act of the Philippines of 1992”.

The public is thus advised to be vigilant and observe precautionary measures in purchasing unregistered pantyliners/sanitary napkins with health claims, false, deceptive and misleading health claims.

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 these products are not sold or made available in the market or areas of jurisdiction.

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.

Attachment-> : FDA Advisory No. 2019-246

FDA Advisory No. 2019-245 || Public Health Warning Against the Purchase and Use of the Unregistered Health Related Device “Megafresh® Compact Alkaline Water Filtration Systems”

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

  1. Megafresh® Compact Alkaline Water Filtration Systems

The FDA verified through post-marketing surveillance that the abovementioned health related device is not registered and the Certificate of Health Related Device Registration (CHRDR) 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 health related device has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety. 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.

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 health related device until CHRDR 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 health related 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. 2019-245

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-245 || Public Health Warning Against the Purchase and Use of the Unregistered Health Related Device “Megafresh® Compact Alkaline Water Filtration Systems”

FDA Advisory No. 2019-228 || Public Health Warning Against the Purchase and Use of the Unregistered Health Related Device “Westinghouse 3 Stage Water Purification System”:

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

The FDA verified through post-marketing surveillance that the above mentioned health related

device is not registered and the Certificate of Heath Related  Device Registration (CHRDR) 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 health related 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 distribute, advertise the violative  product in the market.

All concerned establishments are warned not to distribute, advertise, or sell the said violative

health related device until CHRDR 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 health 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-2019-228

 

/ In Device Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2019-228 || Public Health Warning Against the Purchase and Use of the Unregistered Health Related Device “Westinghouse 3 Stage Water Purification System”:

FDA Advisory No. 2019-227 ||Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “Family Care™ Digital Thermometer”

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™ Digital Thermometer”

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.2019-227

FDA Advisory No. 2019-226 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Curad Sheer 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. “Curad Sheer Bandage”

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.2019-226

FDA Advisory No. 2019-225 || 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. Digital Thermometer
  2. Baby Pacifier Thermometer

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.2019-225

FDA Advisory No. 2019-218 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “INTROCAN® – W (NON- SAFETY)”

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. “INTROCAN® – W (NON- SAFETY)”

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.2019-218

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-218 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “INTROCAN® – W (NON- SAFETY)”

FDA Advisory No. 2019-217 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “KOJAK® SELINGE-SYRINGE WITH NEEDLE”

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. “Coralite® Cold-Wrap Elastic 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.2019-217

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-217 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “KOJAK® SELINGE-SYRINGE WITH NEEDLE”

FDA Advisory No. 2019-216 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “Coralite® Cold-Wrap 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. “Coralite® Cold-Wrap Elastic 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- 216

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-216 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “Coralite® Cold-Wrap Elastic Bandage”

FDA Advisory No. 2019-215 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “Assured® Colored 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.  “Assured® Colored 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.

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.2019-215

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-215 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “Assured® Colored Bandages”:

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