Z-0490-2014 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 25, 2013
- Initiation Date
- October 28, 2013
- Termination Date
- July 6, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,367 untis with affected labeling
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.
Distribution Pattern
USA Nationwide Distribution
Code Information
Item #70-0230; 70-0231; 70-0232; 70-0234; and 70-0235 Document numbers 60-0237 (all) and 60-3003 (all)