Category: Device Advisories

FDA has released a total of 249 COVID – 19 Test Kits (87 – PCR based, 90 – Rapid Antibody, 58 – Immunoassay and 14 – Others)

As of 11 September 2020,  FDA has released a total of 249 COVID – 19 Test Kits (87 – PCR based, 90 – Rapid Antibody , 58 – Immunoassay and 14 – Others).

Click the link below for details.

https://bit.ly/2Zd0CZ4

FDA Advisory No. 2020-1600 || Termination of the Voluntary Product Recall of Terumo® Needle

This is to inform the public and concerned healthcare professionals that the Voluntary recall order issued on selected lots of Terumo® Needle with MDR No. 00802 manufactured by Terumo Philippines Corporation, as shown in the table below is hereby terminated by the Food and Drug Administration (FDA).

As stated in the FDA Advisory No. 2019-079 dated 15 March 2019, Terumo Marketing Philippines Inc. received a customer complaint that the blister seals of the above-mentioned medical device are narrows or misaligned. After the investigation, it was observed that the sealing portion (width) of the blister package was below the manufacturing standard of 1.5mm and a small opening on the package resulting to seal breach. The reason for recall is the potential loss of packaging integrity that may compromise the sterility of the subject medical device product.

After due and thorough evaluation of the submitted documents by Terumo Marketing Philippines Inc., 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 lots 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) 8857-1900 loc. 8301.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2020-1600

FDA Advisory No. 2020-1623 || SAFETY OF RADIOFREQUENCY RADIATION (RFR) EMITTED BY CELL SITES

With reference to the interagency Joint Memorandum Circular No. 1 s. 2020 or the Streamlined Guidelines for the Issuance of Permits, Licenses, and Certificates for the construction of Shared Passive Telecommunications Tower Infrastructure (PTTI ) issued to streamline the process and hasten the construction of more cell site towers across the country, the Food and Drug Administration (FDA) would like to reassure the public that prior to installation of antennas, an evaluation is done to determine its safety.

Cell sites, also known as mobile phone base stations, are required to enable mobile phone communications, calls, and data transfer between wireless telecommunication devices. According to the International Commission on Non-ionizing Radiation (ICNIRP), antennas installed in cell sites emit radiofrequency radiation (RFR), which at very high levels, can heat up body tissues. However, it is very unlikely that a person could be exposed to RFR levels greater than the limits specified by DOH Administrative Order No. 175 s. 2004. Antennas are installed high above cell site towers which ensure minimal exposure at the ground level.

The World Health Organization (WHO) states that there are no adverse effects from typical exposure to RFR produced by cell sites. ‘ Moreover, ICNIRP maintains that any adverse health effect arising from exposure to RFR is only possible at high powered/intensity exposures exceeding limits and safe distances in front of the antennas that are normally inaccessible to the public.2 These values are calculated by the FDA through the issuance of Certificates of Safety Evaluation (CSE) prior to the installation of cell site antennas.

For your guidance.

Attachment:-> FDA Advisory No.2020-1623

FDA has released a total of 249 COVID – 19 Test Kits (87 – PCR based, 90 – Rapid Antibody, 58 – Immunoassay and 14 – Others)

As of 11 September 2020,  FDA has released a total of 249 COVID – 19 Test Kits (87 – PCR based, 90 – Rapid Antibody , 58 – Immunoassay and 14 – Others).

Click the link below for details.

https://bit.ly/2Zd0CZ4

FDA Advisory No. 2020-1508 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product “LUEN MAN FONG BANDAGE-AID ADHESIVE STERILE PLASTERS (IN FOREIGN CHARACTERS)”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unnotified medical device product:

  1. “LUEN MAN FONG BANDAGE-AID ADHESIVE STERILE PLASTERS (IN FOREIGN CHARACTERS)”

The FDA verified through post-marketing surveillance that the above mentioned medical device product is not notified and no corresponding Product Notification Certificate has 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 product has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until the Product Notification Certificate is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been notified with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Notification number on the product label in the form of either DVR-xxx or MDR-xxx or CMDN-xxx.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) 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 unnotified product.

For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected] indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301. 

To report any sale or distribution of unnotified medical device, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1508

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1508 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product “LUEN MAN FONG BANDAGE-AID ADHESIVE STERILE PLASTERS (IN FOREIGN CHARACTERS)”

FDA Advisory No. 2020-1507 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “ACCUMAX NEBULIZING KIT”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unregistered medical device product:

  1. “ACCUMAX NEBULIZING KIT”

The FDA verified through post-marketing surveillance that the above mentioned medical device product is not registered and no corresponding Product Registration Certificate has 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 product has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until the Product Registration Certificate is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product 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. You may also look for the FDA Registration number on the product label in the form of either DVR-xxx or MDR-xxx.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) 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 about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected] indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1507

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1507 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “ACCUMAX NEBULIZING KIT”

FDA Advisory No. 2020-1506 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product “NITRILE DISPOSABLE GLOVES POWDER-FREE, NON-STERILE”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unnotified medical device product:

  1. “NITRILE DISPOSABLE GLOVES POWDER-FREE, NON-STERILE”

The FDA verified through post-marketing surveillance that the above mentioned medical device product is not notified and no corresponding Product Notification Certificate has 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 unnotified medical device product has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until the Product Notification Certificate is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been notified with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Notification number on the product label in the form of either DVR-xxx or MDR-xxx or CMDN-xxx.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) 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 unnotified product.

For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected] indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1506

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1506 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product “NITRILE DISPOSABLE GLOVES POWDER-FREE, NON-STERILE”

FDA Advisory No. 2020-1505 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Products in Foreign Characters:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unnotified medical device products:

  1. 10 mL SYRINGE
  2. 10 mL SYRINGE
  3. 60 mL SYRINGE

The FDA verified through post-marketing surveillance that the above mentioned medical device products are not registered and no corresponding Product Notification Certificate has 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 device products have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device products until the Product Registration Certificates are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product 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. You may also look for the FDA Registration number on the product label in the form of either DVR-xxx or MDR-xxx.

All Law Enforcement agencies (LEAs) and Local Government Units (LGUs) 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 CDRRHR through e-mail at [email protected], indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1505

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1505 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Products in Foreign Characters:

FDA Advisory No. 2020-1473 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “BERTICAR ONE STEP HCG URINE TEST”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unregistered medical device product:

  1. “BERTICAR ONE STEP HCG URINE TEST”

The FDA verified through post-marketing surveillance that the above-mentioned medical device product is not registered and no corresponding product registration certificate has 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 product has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until the product registration certificate is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product 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. You may also look for the FDA Registration number on the product label in the form of either DVR-xxxx or MDR-xxxx.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) 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 these unregistered product.

For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected] indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301.  

To report any sale or distribution of unregistered medical device, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1473

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1473 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “BERTICAR ONE STEP HCG URINE TEST”

FDA Advisory No. 2020-1437 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “LEELVIS NON CONTACT ELECTRONIC THERMOMETER”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unregistered medical device product:

  1. “LEELVIS NON CONTACT ELECTRONIC THERMOMETER”

The FDA verified through post-marketing surveillance that the above mentioned medical device product is not registered and no corresponding product registration certificate has 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 product has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until the product registration certificate is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product 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. You may also look for the FDA Registration number on the product label in the form of either DVR-xxx or MDR-xxx.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) 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 about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected] indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301. 

To report any sale or distribution of unregistered medical device product, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1437

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1437 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “LEELVIS NON CONTACT ELECTRONIC THERMOMETER”

FDA Advisory No. 2020-1435 || Public Health Warning Against the Unapproved and Misleading Health Claims for IonSpec/NanoSpec Medical Eyewear

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public against unapproved and misleading advertisements and promotion of IonSpec/ NanoSpec/ Medical Eyewear:

  1. Online advertisement for the the IonSpec/ NanoSpec Medical Eyewear with Misleading Health Claims

 https://shopee.ph/IonSpec-Medical-Eyewear-or-NanoSpec-i.12710919.2189671785

(Date last accessed: 27 July 2020)

2.  Online advertisement for the Mgi IonSpec M40 Eyeglass with Misleading Health Claims

https://www.lazada.com.ph/products/mgi-ionspec-m40-the-first-and-only-in-the-world-i439524323.html

(Date last accessed: 27 July 2020)

All concerned healthcare professionals and the general public is hereby advised to be vigilant against such deceptive marketing of medical devices. Eyeglasses should not bear any misleading, deceptive and false claims on their advertisements and/or any promotional materials that will provide erroneous impression on the product’s character or identity.

Marketing authorization holders of these medical devices are sternly warned and hereby directed to stop such misleading advertisements and promotions. Appropriate regulatory tools and sanctions shall be executed to such companies that are continuously conducting such and other similar activities upon issuance of this Advisory.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1435

FDA Advisory No. 2020-1546 || Regulation of Face Shield

The Food and Drug Administration (FDA) informs all concerned stakeholders and the general public that face shield is not regulated by the FDA. Thus, no FDA authorization or certification is required for the importation and distribution of face shield.

For more information and inquiries, kindly contact the FDA — Center for Device Regulation, Radiation Health, and Research through e-mail at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1546

FDA Advisory No. 2020-1396 || Public Health Warning Against the Purchase and Use of the Following Misbranded Face Masks in Foreign Characters:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the following misbranded face masks in foreign characters:

  1. Fu Le Bang Disposable Mask
  2. Flag World Face Mask
  3. MAsk

The FDA verified through post-marketing surveillance that the abovementioned medical device products are being offered for sale in the local market.

Section 19(c) of Republic Act (RA) No. 3720 also known as the “Food, Drug, and Cosmetic Act” as amended by RA No. 9711 otherwise known as the “Food and Drug Administration (FDA) Act of 2009” states that “a device shall be deemed misbranded  if any word, statement, or other information required by or under authority of this Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use”. The above-mentioned products are considered misbranded and the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product that is misbranded is prohibited pursuant to Section 10 of RA No. 9711.

In view of the above, all concerned establishments are warned not to distribute, advertise, or sell the said violative medical device products, 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 misbranded products.

For more information and inquiries about this advisory, kindly contact the FDA – CDRRHR through e-mail at [email protected] indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301. 

To report any sale or distribution of the above-mentioned products, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1396

FDA Advisory No. 2020-1388 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “PQ Play Quest Natural Latex Rubber Condom”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unregistered medical device product:

The FDA verified through post-marketing surveillance that the abovementioned medical device product is not registered and no corresponding Product Registration Certificate has 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 product has not gone through the evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until the Product Registration Certificate is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product 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. You may also look for the FDA Registration number on the product label in the form of either DVR-xxx or MDR-xxx.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) 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 about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected], indicating on the subject the concerned advisory or call (02) 8857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device product, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA-Advisory-No.2020-1388

/ In Device Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1388 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “PQ Play Quest Natural Latex Rubber Condom”

FDA Advisory No. 2020-1387 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product “Pediatric Urine Collector”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unnotified medical device product:

The FDA verified through post-marketing surveillance that the abovementioned medical device product is not notified and no corresponding Product Registration Certificate has 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 unnotified medical device product has not gone through the evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until Product Registration Certificate is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product 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. You may also look for the FDA Registration number on the product label in the form of either DVR-xxx, MDR-xxx or CMDN-xxx.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) 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 unnotified product.

For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected], indicating on the subject the concerned advisory or call (02) 8857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device product, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA-Advisory-No.2020-1387

/ In Device Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1387 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product “Pediatric Urine Collector”

FDA Advisory No. 2020-1386 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “PQ Natural Latex Rubber Condoms (0.03)”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unregistered medical device product:

The FDA verified through post-marketing surveillance that the abovementioned medical device product is not registered and no corresponding Product Registration Certificate has 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 product has not gone through the evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until the Product Registration Certificate is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product 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. You may also look for the FDA Registration number on the product label in the form of either DVR-xxx or MDR-xxx.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) 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 about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected], indicating on the subject the concerned advisory or call (02) 8857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device product, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2020-1386

/ In Device Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1386 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “PQ Natural Latex Rubber Condoms (0.03)”

FDA Advisory No. 2020-1379 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “NATURAL LATEX RUBBER CONDOM (IN FOREIGN CHARACTERS)”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unregistered medical device product:

The FDA verified through post-marketing surveillance that the above mentioned medical device product is not registered and no corresponding Product Registration Certificate has 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 product has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until the Product Registration Certificate is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product 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. You may also look for the FDA Registration number on the product label in the form of either DVR-xxx or MDR-xxx.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) 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 about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected] indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301. 

To report any sale or distribution of unregistered medical device, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1379

/ In Device Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1379 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “NATURAL LATEX RUBBER CONDOM (IN FOREIGN CHARACTERS)”

FDA Advisory No. 2020-1382 || Voluntary Recall of “Jamshidi™ Bone Marrow Biopsy/Aspiration Needle, with Luer-Lock Adapter 11GX4 ASP”

The Food and Drug Administration (FDA) warns all healthcare professional and the general public on the voluntary recall of Jamshidi™ Bone Marrow Biopsy/Aspiration Needle, with Luer-Lock Adapter 11GX4 ASP with MDR No. 04161, manufactured by CareFusion DR 203 Ltd. and distributed by Lifelink Inc.:

Product Name Product Code Lot Number
Jamshidi™ Bone Marrow Biopsy/Aspiration Needle, with Luer-Lock Adapter 11GX4 ASP DJ4011X 0001303256
0001303257

Lifelink Inc. received a letter from Becton, Dickinson and Company (BD) informing that the product code and lot number combination of the affected medical device product listed in the table above may be at risk of having some packaging pouches that was not sealed properly. When used, the improperly sealed medical device product may introduce contaminants or disease vectors into the patient’s body which may lead to contamination or infection. At the present, there have been no reported health claims associated to the affected medical device product.

In light of the foregoing, all concerned healthcare professional, establishment, and the general public is warned to discontinue further use, sale, and distribution of the medical device.

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

To report any sale or distribution of unregistered medical device, email us at [email protected].

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

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1382

/ In Device Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1382 || Voluntary Recall of “Jamshidi™ Bone Marrow Biopsy/Aspiration Needle, with Luer-Lock Adapter 11GX4 ASP”

FDA Advisory No. 2020-1385 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unnotified medical device product:

  1. INFUSION SET WITH NEEDLE – 0.6mm
  2. INFUSION SET WITH NEEDLE – 0.55mm
  3. INFUSION SETS FOR SINGLE-USE WITH NEEDLES

The FDA verified through post-marketing surveillance that the above mentioned medical device products are not registered and no corresponding Product Notification Certificates have 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 device products have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device products until CMDR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product 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. You may also look for the FDA Registration number on the product label in the form of either DVR-xxx or MDR-xxx.

All Law Enforcement agencies (LEAs) and Local Government Units (LGUs) 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 CDRRHR through e-mail at [email protected], indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301. 

To report any sale or distribution of unregistered medical device, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1385

FDA Advisory No. 2020-1384 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product “NATURAL LATEX RUBBER CONDOM IN FOREIGN CHARACTERS”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unnotified medical device product:

  1. “NATURAL LATEX RUBBER CONDOM IN FOREIGN CHARACTERS”

The FDA verified through post-marketing surveillance that the above mentioned medical device products is not registered and no corresponding Product Notification Certificate has 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 products have not gone through evaluation process of the FDA, the agency cannot assure their quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device products until CMDR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product 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. You may also look for the FDA Registration number on the product label in the form of either DVR-xxx, MDR-xxx.

All Law Enforcement agencies (LEAs) and Local Government Units (LGUs) 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 CDRRHR through e-mail at [email protected], indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301.  

To report any sale or distribution of unregistered medical device, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1384

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1384 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product “NATURAL LATEX RUBBER CONDOM IN FOREIGN CHARACTERS”

FDA Advisory No. 2020-1383 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “HD® SYRINGE WITH NEEDLE FOR SINGLE USE 50 mL 1.6 x 32mm (IN FOREIGN CHARACTERS)”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unnotified medical device product:

  1. “HD® SYRINGE WITH NEEDLE FOR SINGLE USE 50 mL 1.6 x 32mm (IN FOREIGN CHARACTERS)”

The FDA verified through post-marketing surveillance that the above mentioned medical device products is not registered and no corresponding Product Notification Certificate has 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 products have not gone through evaluation process of the FDA, the agency cannot assure their quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device products until CMDR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product 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. You may also look for the FDA Registration number on the product label in the form of either DVR-xxx, MDR-xxx.

All Law Enforcement agencies (LEAs) and Local Government Units (LGUs) 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 CDRRHR through e-mail at [email protected], indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301.      

To report any sale or distribution of unregistered medical device, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1383

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1383 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “HD® SYRINGE WITH NEEDLE FOR SINGLE USE 50 mL 1.6 x 32mm (IN FOREIGN CHARACTERS)”

FDA Advisory No. 2020-1381 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “ELECTRONIC THERMOMETER TD138”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unnotified medical device product:

  1. “ELECTRONIC THERMOMETER TD138”

The FDA verified through post-marketing surveillance that the above mentioned medical device products is not registered and no corresponding Product Notification Certificate has 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 products have not gone through evaluation process of the FDA, the agency cannot assure their quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device products until CMDR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product 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. You may also look for the FDA Registration number on the product label in the form of either DVR-xxx, MDR-xxx.

All Law Enforcement agencies (LEAs) and Local Government Units (LGUs) 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 CDRRHR through e-mail at [email protected], indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1381

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1381 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “ELECTRONIC THERMOMETER TD138”

FDA Advisory No. 2020-1373 || Public Health Warning Against the Purchase and Use of the Uncertified COVID-19 Test Kit “Wondfo® 2019-nCov in Foreign Characters”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public not to purchase and use of the uncertified COVID-19 test kit:

  1. “Wondfo® 2019-nCov in Foreign Characters”

The FDA verified through post-marketing surveillance that the abovementioned medical device is not certified and/or no FDA Special Certification has been issued as of 08 June 2020. 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 uncertified Covid-19 Antibody Test Kit has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative Covid-19 Antibody Test Kit until the FDA Special Certification is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product 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 Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) 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 uncertified product.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health, and Research through e-mail at [email protected].

To report any sale or distribution of unregistered medical device product, email us at [email protected]

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1373

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1373 || Public Health Warning Against the Purchase and Use of the Uncertified COVID-19 Test Kit “Wondfo® 2019-nCov in Foreign Characters”

FDA Advisory No. 2020-1372 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “Filmed Laboratories Nanosoft™ Microneedles for Intradermal Injection”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unregistered medical device product:

  1. “Filmed Laboratories Nanosoft™ Microneedles for Intradermal Injection”

The FDA verified through post-marketing surveillance that the above mentioned medical device product is not registered and no corresponding product registration certificate has 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 device product has not gone through the evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until the product registration certificate is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product 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. You may also look for the FDA Registration number on the product label in the form of either DVR-XXX or MDR-XXX.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) 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 about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected] indicating on the subject the concerned Advisory, or call (02) 857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device product, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1372

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1372 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “Filmed Laboratories Nanosoft™ Microneedles for Intradermal Injection”

FDA Advisory No. 2020-1371 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “Hearty™ Sodium Hyaluronate Composite Solution for Injection in Foreign Characters”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unregistered medical device product:

  1. “Hearty™ Sodium Hyaluronate Composite Solution for Injection in Foreign Characters”

The FDA verified through post-marketing surveillance that the above mentioned medical device product is not registered and no corresponding product registration certification has been issued. Pursuant to the Republic Act No. 9711, otherwise known as the Food and Drug Administration Act of 2009”, the manufacture, promotion, advertising, and or sponsorship of health products without the proper authorization is prohibited.

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

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until the product registration certification is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a 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. You may also look for the FDA Registration number on the product label in the form of either DVR-XXXX or MDR-XXXX.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) 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 about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected] indicating on the subject the concerned Advisory, or call (02) 857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device product, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1371

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1371 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “Hearty™ Sodium Hyaluronate Composite Solution for Injection in Foreign Characters”

FDA Advisory No. 2020-1370 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product SMILEPLUS CLEAR PLASTERS

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unnotified medical device product:

  1. SMILEPLUS CLEAR PLASTERS

The FDA verified through post-marketing surveillance that the above mentioned medical device product is not notified and no corresponding Product Notification Certificate has 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 unnotified medical device has not gone through evaluation process of the FDA, the agency cannot assure their quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until the Product Notification Certificate is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product 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. You may also look for the FDA Notification number on the product label in the form of CMDN-xxx, and DVR-xxx MDR-xxx.

All Law Enforcement agencies (LEAs) and Local Government Units (LGUs) 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 unnotified product.

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

To report any sale or distribution of unregistered medical device product, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1370

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1370 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product SMILEPLUS CLEAR PLASTERS

FDA Advisory No. 2020-1369 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device Product UNI-T UT300R Non-Contact Infrared Thermometer Thermal

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unregistered medical device product:

  1. UNI-T UT300R Non-Contact Infrared Thermometer Thermal

The FDA verified through post-marketing surveillance that the above mentioned medical device product is not registered and no corresponding Product Registration Certificate has 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 their quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until the Product Registration Certificate is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product 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. You may also look for the FDA Registration number on the product label in the form of either DVR-xxx or MDR-xxx.

All Law Enforcement agencies (LEAs) and Local Government Units (LGUs) 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) 8857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device product, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1369

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1369 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device Product UNI-T UT300R Non-Contact Infrared Thermometer Thermal

FDA Advisory No. 2020-1368 || Public Health Warning Against the Purchase and Use of the Misbranded In Vitro Diagnostic (IVD) Medical Device “On Call EZ II Blood Glucose Test Strips in Foreign Characters”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the misbranded in-vitro diagnostic medical device “On Call EZ II Blood Glucose Test Strips” in foreign characters:

  1. “On Call EZ II Blood Glucose Test Strips in Foreign Characters”

The FDA verified through post-marketing surveillance that the abovementioned medical device product is being offered for sale in the local market.

Section 19(c) of Republic Act (RA) No. 3720 also known as the “Food, Drug, and Cosmetic Act” as amended by RA No. 9711 otherwise known as the “Food and Drug Administration (FDA) Act of 2009” states that “a device shall be deemed misbranded  if any word, statement, or other information required by or under authority of this Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use”. The above-mentioned product is considered misbranded and the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product that is misbranded is prohibited pursuant to Section 10 of RA No. 9711.

The use of the said IVD medical device could lead to inaccurate result; thus, could compromise the health and safety of the user.

In view of the above, all concerned establishments are warned not to distribute, advertise, or sell the said violative medical device products, 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 misbranded product.

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

To report any sale or distribution of unregistered medical device product, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1368

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1368 || Public Health Warning Against the Purchase and Use of the Misbranded In Vitro Diagnostic (IVD) Medical Device “On Call EZ II Blood Glucose Test Strips in Foreign Characters”

FDA Advisory No. 2020-1367 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product “/.M® PLASTIC BANDAGE TRANSPARENT – STERILE BREATHABLE WATERPROOF”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unnotified medical device product:

  1. “/.M® PLASTIC BANDAGE TRANSPARENT – STERILE BREATHABLE WATERPROOF”

The FDA verified through post-marketing surveillance that the above mentioned medical device product is not notified and no corresponding Product Notification Certificate has 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 unnotified medical device product has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until the Product Notification Certificate is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been notified with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration/Notification number on the product label in the form of either DVR-xxxx or MDR-xxxx or CMDN-xxx.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) 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 unnotified product.

For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected] indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device product, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1367

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1367 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product “/.M® PLASTIC BANDAGE TRANSPARENT – STERILE BREATHABLE WATERPROOF”

FDA Advisory No. 2020-1366 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “Intravenous (IV) Set in Foreign Characters”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unregistered medical device product:

  1. “Intravenous (IV) Set in Foreign Characters”

The FDA verified through post-marketing surveillance that the abovementioned medical device product is not registered and no corresponding Product Registration Certificate has 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 product has not gone through the evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until the Product Registration Certificate is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product 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. You may also look for the FDA Registration number on the product label in the form of either DVR-xxx or MDR-xxx.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) 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 about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected], indicating on the subject the concerned advisory or call (02) 8857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device product, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1366

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1366 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “Intravenous (IV) Set in Foreign Characters”
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