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
- Recall Number
- Z-0490-2014
- Event Number
- 66735
- Firm
- Nephros Inc
- FEI Number
- 3003337893
- Status
- Terminated
- Root Cause
- Labeling False and Misleading
- Initiated
- October 28, 2013
- Posted
- December 17, 2013
- Terminated
- July 6, 2016
- Address
- 41 Grand Ave, River Edge, NJ, 07661-1947
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.
Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device.
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
USA Nationwide Distribution
3,367 untis with affected labeling