FDA-Device2013-12-25Class I
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
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
3742 units
Manufactured in
41 Grand Ave, N/A, River Edge, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0487-2014Don't want to check this manually?
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