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U.S. Department of Health and Human Services

Enforcement Report - Week of December 26, 2013

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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

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 Item Number 70-0236 and 70-0237 all lots Document number 60-0237, 60-3004 and 60-3005 - all documents Class I Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device. 3472 SS units; 513 FH units; 1219 HH units Z-0488-2014
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 Item Number 70-023 and 70-0238 all lots Document number 60-0237, 60-3004 and 60-3005 - all documents Class I Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device. 3742 units Z-0487-2014
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