FDA-Device2013-12-25Class I
1) Nephros SafeShower FH - 15 filters per box; item no. 70-0236 2) Nephros SafeShower HH -6 filters per box ; item no. 10-0237 Manufactured by : Nephros, Inc. 41 Grand Ave, River Edge, NJ 07661 Assembled at MEDICA 41036 Medolla, Italy 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
Nephros Inc
Hazard
Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device.
Sold states
Nationwide Distribution
Affected count
3472 SS units; 513 FH units; 1219 HH units
Manufactured in
41 Grand Ave, N/A, River Edge, NJ, United States
Products
1) Nephros SafeShower FH - 15 filters per box; item no. 70-0236 2) Nephros SafeShower HH -6 filters per box ; item no. 10-0237 Manufactured by : Nephros, Inc. 41 Grand Ave, River Edge, NJ 07661 Assembled at MEDICA 41036 Medolla, Italy 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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0488-2014Don't want to check this manually?
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