Recall Z-0487-2014— 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: 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. 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
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
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.