Z-0488-2014 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 25, 2013
- Initiation Date
- October 28, 2013
- Termination Date
- June 28, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3472 SS units; 513 FH units; 1219 HH units
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.
Distribution Pattern
Nationwide Distribution
Code Information
Item Number 70-0236 and 70-0237 all lots Document number 60-0237, 60-3004 and 60-3005 - all documents