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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 Dual Stage Ultra Filter (DSU) Brochure Document 60-3003 Revisions: 0, 1, 2 Product Usage: A disposable point of use water ultrafilter that delivers microbiologically pure water for washing and drinking.
Recall Number Z-0490-2014
Classification Class I
Code Info Item #10-0230; 70-0231; 70-0232; 70-0234; and 70-0235 Document numbers 60-0237 (all) and 60-3003 (all)
Product Distributed Qty 3,367 untis with affected labeling
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 66735
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 USA Nationwide Distribution