BEUDAMED
    FDA Enforcement Class I Terminated

    Nephros SafeSpout Manufacturer: Nephros Inc. 41 Grand Avenue, River Edge, NJ 07661 Assembled at : MEDICA 41036 Medolla, Italy Filters are packaged in a Tyvek pouch and then placed inside a cardboard box. 15 filters per box 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-0487-2014 · Reported December 25, 2013

    Enforcement

    Recall Number
    Z-0487-2014
    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

    Nephros SafeSpout Manufacturer: Nephros Inc. 41 Grand Avenue, River Edge, NJ 07661 Assembled at : MEDICA 41036 Medolla, Italy Filters are packaged in a Tyvek pouch and then placed inside a cardboard box. 15 filters per box 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 70-023 and 70-0238 all lots Document number 60-0237, 60-3004 and 60-3005 - all documents

    Distribution

    Nationwide Distribution

    Quantity

    3742 units