Medical Devices

Nephros Water Filtration Products (exposure to bacteria or virus)

Recall Class: Class I

Date Recall Initiated: October 28, 2013

Products: SafeSpout, SafeShower HH (Hand Held), SafeShower FH (Fixed Head)

These affected products were distributed from October, 2011 through September, 2013.

Use: 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 head.

Recalling Firm:
Nephros Inc.
41 Grand Ave.
River Edge, NJ 07661-1947

Manufacturer:
Nephros Inc.
41 Grand Ave.
River Edge, NJ 07661-1947

Reason for Recall: The Nephros non-medical water filtration SafeSpout and SafeShower products may pose risks to health potentially resulting in adverse health events or death. Exposure to harmful bacteria may occur when the fiber filter or the sealing compound, holding the fiber in place, breaks apart. If the filter breaks, patients could be exposed to bacteria or viruses, which could result in infection or death. To date, reports of one death and one infection are associated with this recall.

Public Contact: For questions about this action you may contact Nephros Inc. at: 1-201-343-5202 x100 between the hours of 9:30 a.m. to 5 p.m. ET, Monday through Friday.

FDA District: New Jersey District Office

FDA Comments:

Health Care Professionals: No action is required beyond the recommendations provided in the Urgent Medical Device Recall Notification disclaimer icon

On October 28, 2013, Nephros sent customers recall letters and return response forms via UPS. Customers are asked to provide a contact information list and remove and return filters. All related promotional materials should be discarded.

For questions about this action you may contact Nephros Inc. at: 1-201-343-5202 x100 between the hours of 9:30 a.m. to 5 p.m. ET, Monday through Friday.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail, or by FAX.