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Terminated

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.

FDA Recall Z-0490-2014 · Posted 2013-12-17

Recalling FirmNephros Inc
Recall StatusTerminated
Date Initiated2013-10-28
Date Terminated2016-07-06
Product Quantity3,367 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.

Firm 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

Root Cause

Labeling False and Misleading

Distribution Pattern

USA Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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