January 7, 2013 — The SafeSpout and SafeShower water filters, manufactured by Nephros, have been withdrawn in a Class 1 recall after they were associated with one report of death and one infection.
The SafeSpout and SafeShower are installed at the end of a standard sink faucet or shower head. They are intended to filter harmful bacteria and viruses in water used for drinking and washing. They are not complete water treatment systems.
The FDA has warned Nephros that the products are supposed to be non-medical, but promotional claims have marketed them as medical devices. Nephros recommends that all related promotional materials should be discarded.
The problem is that the fiber filter or the sealing compound that holds the fiber in place can break apart, which could expose users to a risk of infection. Nephros has received at least 29 complaints about high bacterial counts that may be associated with a broken filter.
The affected products were distributed from October 2011 through September 2013. Designs include hand-held and fixed-head models. All lots have been recalled.
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