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Nephros Inc recalls Nephros SafeSpout Manufacturer: Nephros Inc. 41 Grand Avenue, River Edge, NJ 07661 Assembled at : MEDICA 41036 Medolla
Recalled December 25, 2013 · FDA recall Z-0487-2014 · Nephros
Hazard
Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device. · FDA Class I
Units
3742 units
Sold at
Nationwide Distribution
Description
Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device.
Product
Nephros SafeSpout Manufacturer: Nephros Inc. 41 Grand Avenue, River Edge, NJ 07661 Assembled at : MEDICA 41036 Medolla, Italy Filters are packaged in a Tyvek pouch and then placed inside a cardboard box. 15 filters per box 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 hose
Manufacturer(s)
Nephros Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →