Alerta De Seguridad para Unimex® Volumetric Infusion Set with Burette 100cc

Safety alert

2018-243

Philippines

FDAP

https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/525467-fda-advisory-no-2018-243

Fda advisory no. 2018-243 public health warning against the purchase and use of unregistered unimex® volumetric infusion set with burette 100cc as medical device product the food and drug administration (fda) advises the general public and all healthcare professionals, establishment and general consuming public against the purchase and use of the unimex® volumetric infusion set with burette 100cc as unregistered medical device product: fda post-marketing surveillance (pms) activities have verified that the abovementioned medical device product have not gone through the registration process of the agency and have not been issued with proper authorization in the form of certificate of product registration (cpr).Pursuant to republic act 9711, otherwise known as the “food and drug administration act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from fda is prohibited. accordingly, since this unregistered medical device have not gone through evaluation and testing process of the fda, the agency cannot guarantee its quality and safety. the consumption of such violative product may pose potential health hazards to the consuming public. in light of the above, the public is advised not to purchase the aforementioned violative products and to be vigilant against medical device that might not be duly registered with fda. always check if a medical device has been registered with the fda before purchasing it by making use of the embedded search feature of the fda website accessible at www.Fda.Gov.Ph.  all concerned establishments and/or entities are warned not to distribute the above-identified violative medical device products until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.  all local government units (lgus) and law enforcement agencies (leas) are requested to ensure that this product is not sold or made available in their localities or areas of jurisdiction.  for more information and inquiries, please e-mail us at this email address is being protected from spambots. you need javascript enabled to view it. , or call us at the center for device regulation, radiation health and research (cdrrhr) hotline (02) 857-1900 local 8301. dissemination of the information to all concerned is requested. attachments: fda advisory no. 2018-243.Pdf.