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U.S. Department of Health and Human Services

Class 1 Device Recall Nephros Dual Stage Ultra Filter

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 Class 1 Recall
Nephros Dual Stage Ultra Filter
see related information
Date Posted December 17, 2013
Recall Status1 Open
Recall Number Z-0490-2014
Recall Event ID 66735
Product 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.
Code Information Item #70-0230; 70-0231; 70-0232; 70-0234; and 70-0235 Document numbers 60-0237 (all) and 60-3003 (all)
Recalling Firm/
Manufacturer
Nephros Inc
41 Grand Ave
River Edge, New Jersey 07661-1947
For Additional Information Contact Ms. Eileen Sukumaran
201-343-5202
Manufacturer 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.
FDA Determined
Cause 2
MISBRANDING: Labeling False and Misleading
Action Nephros Inc., sent an Urgent Medical Device Recall letter dated October 29, 2013 to all affected customers via UPS 2nd Day Air. The letter identified the affected product, problem and actions to be taken. Customer are asked to provide a customer information list, immediately remove and discard all affected product labeling materials and any independent labeling materials they have created for the affected products. Customers are instructed to complete and sign the attached Response Form to acknowledge receipt, understanding and compliance with the instruction. For questions contact the Nephros representative at 201-343-5202 x 100. The letter was also posted at : http://www.nephros.com/download/news/DSU_Recall_Letters.pdf.
Quantity in Commerce 3,367 untis with affected labeling
Distribution USA Nationwide Distribution

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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