Z-0487-2014 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
- 3742 units
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.
Distribution Pattern
Nationwide Distribution
Code Information
Item Number 70-023 and 70-0238 all lots Document number 60-0237, 60-3004 and 60-3005 - all documents