BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-2133-2016 · Reported July 13, 2016

    Enforcement

    Recall Number
    Z-2133-2016
    Event ID
    74329
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Lifeline First Aid LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 13, 2016
    Initiation Date
    May 16, 2016
    Classification Date
    July 6, 2016
    Termination Date
    February 22, 2017
    Address
    26200 SW 95th Ave Ste 302, N/A, Wilsonville, OR, 97070-8204, United States

    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.

    Code Info

    Exp Dates/Lot # Jan-16; 14181 Nov-16; 15077 Nov-16; 15097 Mar-17; 15278 Oct-17; 16068

    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