Recall Z-0490-2014— Nephros Inc
Class I · Terminated
Class I FDA medical device recall by Nephros Inc, initiated 2013-10-28, terminated 2016-07-06. FDA's recall record names no specific 510(k) clearance for this event. Product: Nephros Dual Stage Ultra Filter (DSU) Brochure Document 60-3003 Revisions: 0, 1, 2 Product Usage: A disposable point of use water ultrafilter that delivers microbiologically pure water for washing and drinking.. Reason: Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device..
- Recalling firm
- Nephros Inc
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2013-10-28
- Terminated
- 2016-07-06
- Firm location
- River Edge, NJ, United States
Product description
Nephros Dual Stage Ultra Filter (DSU) Brochure Document 60-3003 Revisions: 0, 1, 2 Product Usage: A disposable point of use water ultrafilter that delivers microbiologically pure water for washing and drinking.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.