Nephros Filtration Products: Class I Recall
MedSun: Newsletter #91, January 2014

FDA MedWatch Safety Alert

The Nephros 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. 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) and 60-3003 Nephros In-Line DSU Filter Brochure.


Additional Information:

Nephros Filtration Products: Class I Recall. FDA MedWatch Safety Alert. January 7, 2014.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm380473.htm


MedSun Newsletters are available at www.fda.gov/cdrh/medsun