BEUDAMED
    FDA Enforcement Class II Terminated

    CPR Shield With One Way Valve and Barrier Filter, Reorder No. 4921 --- Dynarex label, 100 per case --- Manufactured for: Dynarex Corporation - Made in China. Used as a physical barrier for mouth to mouth resuscitation.

    Recall: Z-2117-2014 · Reported August 6, 2014

    Enforcement

    Recall Number
    Z-2117-2014
    Event ID
    68681
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Dynarex Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 6, 2014
    Initiation Date
    July 2, 2014
    Classification Date
    July 25, 2014
    Termination Date
    April 20, 2017
    Address
    10 Glenshaw St, Orangeburg, NY, 10962-1207, United States

    Description

    CPR Shield With One Way Valve and Barrier Filter, Reorder No. 4921 --- Dynarex label, 100 per case --- Manufactured for: Dynarex Corporation - Made in China. Used as a physical barrier for mouth to mouth resuscitation.

    Reason

    "THIS SIDE UP" is on the wrong side of the product. This error poses a potential health hazard if the wrong labeling is followed by caregivers.

    Code Info

    Lot Numbers 28619 & 28621

    Distribution

    Worldwide Distribution -- USA, Canada, and Mexico.

    Quantity

    Domestic: 208 cases; Foreign: 42 cases