FDA Recall Terminated

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 hose

Recall: Z-0487-2014 · Initiated October 28, 2013

Recall

Recall Number: Z-0487-2014
Event Number: 66736
Firm: Nephros Inc
FEI Number: 3003337893
Product Code: ND
Status: Terminated
Root Cause: Device Design
Initiated: October 28, 2013
Posted: December 17, 2013
Terminated: June 28, 2017
Address: 41 Grand Ave, River Edge, NJ, 07661-1947

Description

Reason

Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device.

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 any publicly accessible locations (e.g. website). Customers with questions were instructed to contact their Nephros representative or call 201-343-5202, ext 100. For questions regarding this recall call 201-343-5202. The letter was also posted at: http://www.nephros.com/download/news/SafeSpout_SafeShower_Recall_Letters.pdf Nephros sent a new recall letter dated 2/20/204 as they determined they have additional customers.

Distribution

Nationwide Distribution

Quantity

3742 units