The Nephros non-medical water filtration SafeSpout, SafeShower HH (Hand Held), SafeShower FH (Fixed Head) have been recalled because the products may pose risks to health potentially resulting in adverse health events or death. 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 could result in infection or death.
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. The recalled products were distributed from October, 2011 through September, 2013. To date, reports of one death and one infection are associated with this recall.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
See the FDA Announcement