BEUDAMED
    FDA Enforcement Class I Terminated

    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.

    Recall: Z-0490-2014 · Reported December 25, 2013

    Enforcement

    Recall Number
    Z-0490-2014
    Event ID
    66735
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Nephros Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 25, 2013
    Initiation Date
    October 28, 2013
    Classification Date
    December 17, 2013
    Termination Date
    July 6, 2016
    Address
    41 Grand Ave, N/A, River Edge, NJ, 07661-1947, United States

    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

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

    Code Info

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

    Distribution

    USA Nationwide Distribution

    Quantity

    3,367 untis with affected labeling