• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of December 26, 2013

  • Print
  • Share
  • E-mail
-

Product Detail

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
Recall Number Z-0488-2014
Classification Class I
Code Info Item Number 70-0236 and 70-0237 all lots Document number 60-0237, 60-3004 and 60-3005 - all documents
Product Distributed Qty 3472 SS units; 513 FH units; 1219 HH units
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.

Event Detail

Event Id 66736
Product Type Devices
Status Ongoing
Recalling Firm Nephros Inc
City River Edge
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-10-28
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution
-
-