BEUDAMED
    FDA Recall 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 · Initiated July 2, 2014

    Recall

    Recall Number
    Z-2117-2014
    Event Number
    68681
    Firm
    Dynarex Corporation
    FEI Number
    2431014
    Product Code
    CBP
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    July 2, 2014
    Posted
    July 25, 2014
    Terminated
    April 20, 2017
    Address
    10 Glenshaw St, Orangeburg, NY, 10962-1207

    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.

    Action

    Voluntary Device Recall letters (dated 7/01/14) and recall verification forms were sent to customers via US Postal First Class Mail on 7/02/14. The letters instructed customers to check their inventory for the specific lots, discontinue distributing them, and quarantine them immediately. Customers were to promptly contact Dynarex Credit & Return Representative Avi Celnick at 1-845-365-8200 ext. 6644 to arrange for product return and obtain an RGA #. For questions, please call Dynarex's toll free number 1-888-396-2739.

    Distribution

    Worldwide Distribution -- USA, Canada, and Mexico.

    Quantity

    Domestic: 208 cases; Foreign: 42 cases