BEUDAMED
    FDA Enforcement Class I Terminated

    1) Nephros SafeShower FH - 15 filters per box; item no. 70-0236 2) Nephros SafeShower HH -6 filters per box ; item no. 10-0237 Manufactured by : Nephros, Inc. 41 Grand Ave, River Edge, NJ 07661 Assembled at MEDICA 41036 Medolla, Italy The Nephros SafeSpout and SafeShower are intended to filter water for washing and drinking. They are intended to be installed at the end of a standard sink faucet or shower hose

    Recall: Z-0488-2014 · Reported December 25, 2013

    Enforcement

    Recall Number
    Z-0488-2014
    Event ID
    66736
    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
    June 28, 2017
    Address
    41 Grand Ave, N/A, River Edge, NJ, 07661-1947, United States

    Description

    1) Nephros SafeShower FH - 15 filters per box; item no. 70-0236 2) Nephros SafeShower HH -6 filters per box ; item no. 10-0237 Manufactured by : Nephros, Inc. 41 Grand Ave, River Edge, NJ 07661 Assembled at MEDICA 41036 Medolla, Italy The Nephros SafeSpout and SafeShower are intended to filter water for washing and drinking. They are intended to be installed at the end of a standard sink faucet or shower hose

    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 Number 70-0236 and 70-0237 all lots Document number 60-0237, 60-3004 and 60-3005 - all documents

    Distribution

    Nationwide Distribution

    Quantity

    3472 SS units; 513 FH units; 1219 HH units