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U.S. Department of Health and Human Services

Enforcement Report - Week of December 26, 2013

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Product Detail

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
Recall Number Z-0487-2014
Classification Class I
Code Info Item Number 70-023 and 70-0238 all lots Document number 60-0237, 60-3004 and 60-3005 - all documents
Product Distributed Qty 3742 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
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