Alerta De Seguridad para Aguahome (sistema de purification) Agualife 2.0 Water Purifier

Safety alert

2018-268

Philippines

FDAP

https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/525501-fda-advisory-no-2018-268

Fda advisory no. 2018-268 public health warning against the purchase and use of unregistered aguahome (sistema de purificacion) agualife 2.0 water purifier  as health related device  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 aguahome (sistema de purification) agualife 2.0 water purifier as unregistered health related device product: fda post-marketing surveillance (pms) activities have verified that the abovementioned health related device product has not gone through the registration process of the agency and has 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 health related device has 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. furthermore, any unsubstantiated claims are strictly prohibited to use in any products. the claim of alkaline water as product water by this health related device is also not allowed (fda advisory numbers 2011-013 and 2014-010). in light of the above, the public is advised not to purchase the aforementioned violative product and to be vigilant against health related device that might not be duly registered with fda. always check if a health related 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 product 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. 2018-268.Pdf.