Recall Z-0488-2014— Nephros Inc
Class I · Terminated
Class I FDA medical device recall by Nephros Inc, initiated 2013-10-28, terminated 2017-06-28. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. Reason: Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device..
- Recalling firm
- Nephros Inc
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2013-10-28
- Terminated
- 2017-06-28
- Firm location
- River Edge, NJ, United States
Product description
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
Reason for recall
Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device.
Data sourced from openFDA. This site is unofficial and independent of the FDA.