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Recall Observatory FDA recall evidence

Device 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.

Z-0490-2014

October 28, 2013

Class I

Product summary

Firm
Nephros Inc
Event
Event 66735
Status
Terminated
Classification
Class I
Quantity
3,367 untis with affected labeling
Official record key
device-enforcement:Z-0490-2014

Official wording

Reason: Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device.

Code information: Item #70-0230; 70-0231; 70-0232; 70-0234; and 70-0235 Document numbers 60-0237 (all) and 60-3003 (all)

Distribution pattern: USA Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device.