Medical Devices

Nephros Filtration Products (labeling promoting medical claims)

Recall Class: Class I

Date Recall Initiated: October 28, 2013

Products: In-Line Dual Stage Ultra (DSU) Filter

These affected products (Item #s 70-0230, 70-0231, 70-0232, 70-0234 and 70-0235) were distributed from January, 2011 through October, 2013.

Use: The Nephros In-Line DSU Filter is a disposable filter that delivers microbiologically pure water for washing and drinking. The DSU Filter is not a complete water treatment system but it serves to remove biological contaminants.

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: Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device. The affected marketing materials include the following document numbers:

  • 60-0237 Nephros Ultrafilters Technical Dossier (Infection Control)
  • 60-3003 Nephros In-Line DSU Filter Brochure

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.

Page Last Updated: 01/06/2014
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