Recall Z-0487-2014 ยท ND
Nephros Inc
Nephros SafeSpout Manufacturer: Nephros Inc. 41 Grand Avenue, River Edge, NJ 07661 Assembled at : MEDICA 41036 Medolla, Italy Filters are packaged in a Tyvek pouch and then placed inside a cardboard box. 15 filters per box The Nephros SafeSpout and SafeShower are intended to filter water for washing and drinking. They are intended to be installed at the end of a standard sink faucet or shower hos
| 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 | Device Design |
| Action | Nephros sent an Urgent Medical Device Recall letter dated October 28, 2013, with a return response form to all affected customers via UPS 2nd Day Air. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to cease shipment of the affected product immediately. Obtain an RGA number to return the new and used filters for credit. In addition, customers were instructed to immediately remove and discard all copies of the labeling materials that pertain to the affected product. Remove all electronic copies of these materials from a |
| Quantity | 3742 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.