FDA Advisory No. 2017-320
Public Health Warning Against the Use of Unregistered Medical Device (Sutures)
The Food and Drug Administration (FDA) hereby advises all concerned healthcare professionals, establishments and general consuming public against the purchase and use of ETHICON SUTURES whose pictures appear below.
has not been issued with proper authorization in the form of Certificate of Product Registration. Pursuant to the provisions of 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 any health product that is adulterated, unregistered or misbranded are prohibited.
The abovementioned products did not undergo the evaluation process of the FDA. Thus, the agency cannot guarantee their quality and safety.
Furthermore, FDA, in coordination with the Market Authorization Holder (MAH), Johnson & Johnson Philippines, Inc., has verified that the above-stated medical device products are counterfeit.
In this regard, the public is hereby advised not to purchase the above-mentioned violative products and to be vigilant against the medical device products that are not registered with the FDA.
Distributors, retailers, hospitals and all healthcare professionals/users are advised to discontinue further distribution, sale and use of the said medical device products.
All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.
Dissemination of the information to all concerned is requested.