Nephros Inc
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.
| Date | Dec 17, 2013 (initiated Oct 28, 2013) |
| Status | Terminated |
| Reason | Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device. |
| Root cause | 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 Ne |
| Quantity | 3,367 untis with affected labeling |
| Distribution | USA Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.