Class 1 Device Recall Nephros SafeShower

• Date Initiated by Firm: October 28, 2013
• Date Posted: December 17, 2013
• Recall Status: Terminated on June 28, 2017
• Recall Number: Z-0488-2014
• Recall Event ID: 66736
• Product Classification: Nephros SafeShower - Product Code ND
• Product: 1) Nephros SafeShower FH - 15 filters per box; item no. 70-0236 2) Nephros SafeShower HH -6 filters per box ; item no. 10-0237 Manufactured by : Nephros, Inc. 41 Grand Ave, River Edge, NJ 07661 Assembled at MEDICA 41036 Medolla, Italy 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
• Code Information: Item Number 70-0236 and 70-0237 all lots Document number 60-0237, 60-3004 and 60-3005 - all documents
• Recalling Firm/ Manufacturer: Nephros Inc; 41 Grand Ave; River Edge NJ 07661-1947
• For Additional Information Contact: Ms. Eileen Sukumaran; 201-343-5202
• Manufacturer 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.
• FDA Determined 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 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.
• Quantity in Commerce: 3472 SS units; 513 FH units; 1219 HH units
• Distribution: Nationwide Distribution

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.