FDAFDA · Food and drugs·Recall number Z-0490-2014
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.
Published December 25, 2013 · Recall initiated: October 28, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Nephros Inc
- Distributor
- USA Nationwide Distribution
- Lot
- Item #70-0230; 70-0231; 70-0232; 70-0234; and 70-0235 Document numbers 60-0237 (all) and 60-3003 (all)
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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