FDA Advisory No. 2017-185
Public Health Warning Against the Purchase and Use of Medical Device (Clinical Thermometer included in Playtex Baby Healthcare Kit) that are Unregistered.
The Food and Drug Administration (FDA) advises the public against the purchase and use of unregistered medical device - Clinical Thermometer included in Playtex Baby Healthcare Kit.
Post-marketing surveillance activities conducted by the FDA have verified that Playtex Baby 6pc, Healthcare Kit (see Figure 1 and 2) have not gone through the registration process of the agency and have not been issued with Certificate of Product Registration (CPR).
Pursuant to the provisions of Republic Act 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization are prohibited.
Since the abovementioned products did not undergo the evaluation process of the FDA, the agency cannot guarantee their quality and safety.
In this regard, the public is hereby advised not to purchase the above-mentioned violative products. All concerned establishments are warned not to advertise, sell or distribute the said products until such have been issued with the corresponding Cerificate of Product Registration, otherwise, regulatory actions and sanctions shall be strictly pursued.
All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.
Dissemination of the information to all concerned is requested.