Nephros SafeSpout Manufacturer: Nephros Inc. 41 Grand Avenue, River Edge, NJ 07661 Assembled at : MEDICA 41036 Medolla,

FDA device recall Z-0487-2014 · posted 2013-12-17 · Terminated

Recall details

Recalling firm

Nephros Inc

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.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

ND

Quantity affected

3742 units

Distribution

Nationwide Distribution

Date initiated

2013-10-28

Date posted

2013-12-17

Date terminated

2017-06-28

Location

River Edge, NJ