BEUDAMED
    FDA Recall Terminated

    5195GM, Cadillac First Aid Kit, #23459698, brand General Motors. No UPC.

    Recall: Z-2133-2016 · Initiated May 16, 2016

    Recall

    Recall Number
    Z-2133-2016
    Event Number
    74329
    Firm
    Lifeline First Aid LLC
    FEI Number
    3002714597
    Product Code
    CBP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 16, 2016
    Posted
    July 6, 2016
    Terminated
    February 22, 2017
    Address
    26200 SW 95th Ave, Ste 302, Wilsonville, OR, 97070-8204

    Description

    5195GM, Cadillac First Aid Kit, #23459698, brand General Motors. No UPC.

    Reason

    Cadillac First Aid Kit is recalled because it contains the CPR Shield with One Way Valve and Barrier Filter (mask) and this mask is cleared only for prescription use and is not cleared for over-the-counter (OTC) use.

    Action

    The firm sent the PRODUCT RECALL NOTICE- LIFELINE FIRST AID KITS WHICH INCLUDE CPR MASK letter, dated 5/11/2016, to their consignees. CPR shields will be replaced without charge and acceptable Lifeline First Aid kits will be re-worked and returned using our standard RGA process. In addition, the firm sent the PRODUCT RECALL NOTICE- CADILLAC FIRST AID KIT letter, dated May 31, 2016, to General Motors. General Motors will be sending out a dealership bulletin to inform their customers of this issue. Once confirmed, replacement masks will be sent to the requested dealerships and made available to be ordered (at no cost) as needed. Please complete and fax the attached Customer Response Form to Lifeline at (503)783-3721. Consignees with questions should call Lifeline First Aid, LLC at (503)783-3660.

    Distribution

    Distributed in AZ, CA, CO, FL, GA, IL, KY, MD, MN, MO, MT, NE, NJ, NY, OK, OR, PA, SC, TN, UT, VA, WA, WA, and WI. Also distributed in New Zealand.

    Quantity

    2975 kits