Washington, DC: The Food and Drug Administration (FDA) has issued a class one recall following reports of death and infection associated with the Nephros non-medical water filtration SafeSpout and SafeShower products. The Nephros SafeSpout and SafeShower are intended to filter water for washing and drinking. They are intended to be installed at the end of a standard sink faucet or shower head.
Exposure to harmful bacteria may occur when the fiber filter or the sealing compound, holding the fiber in place, breaks apart. If the filter breaks, patients could be exposed to bacteria or viruses, which, the FDA notes, could result in infection or death. To date, reports of one death and one infection are associated with this recall.
This recall involves all production lots of the following point-of-use (POU) filters, manufactured between July 2011 and September 2013 and distributed between October 2011 and October 2013:
SafeSpout 70-0233, 70-0238
SafeShower HH (Hand Held) 70-0237
SafeShower FH (Fixed Head) 70-0236
