Nephros Filtration Products: Class I Recall - Labeling Promoting Medical Claims

[Posted 01/07/2013]

AUDIENCE: Biomedical Engineer, Risk Manager

ISSUE: 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

BACKGROUND: The Nephros In-Line In-Line Dual Stage Ultra (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. These affected products (Item #s 70-0230, 70-0231, 70-0232, 70-0234 and 70-0235) were distributed from January, 2011 through October, 2013.

RECOMMENDATION: On October 28, 2013, Nephros sent customers recall letters and return response forms via UPS. All related promotional materials should be discarded.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[01/06/2013 - Recall Notice - FDA]