BEUDAMED
    FDA Enforcement Class II Terminated

    Performance-LOAD Ambulance Cot Fastener Stretcher, Wheeled

    Recall: Z-0739-2017 · Reported December 21, 2016

    Enforcement

    Recall Number
    Z-0739-2017
    Event ID
    75820
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Medical Division of Stryker Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 21, 2016
    Initiation Date
    November 8, 2016
    Classification Date
    December 12, 2016
    Termination Date
    January 16, 2018
    Address
    3800 E Centre Ave, Portage, MI, 49002-5826, United States

    Description

    Performance-LOAD Ambulance Cot Fastener Stretcher, Wheeled

    Reason

    Stryker Medical initiated a voluntary recall of Stryker Performance-LOAD Cot Fasteners due to complaints that fastening system may not have been securely fastened or had an inability to fasten into the Performance-LOAD and bounced back during loading which could cause injury to consumers.

    Code Info

    Model(s): 6392-000-001, 6392-000-002, 6393-000-003, 6393-000-004; GTIN: 07613327282542, 07613327282603, 07613327282597, 07613327282610

    Distribution

    Worldwide Distribution to AK, AL , AR , AZ , CA , CT , DC , DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA , RI, SC, TN, TX, UT,VA, VT ,WA ,WV ,WY and Internationally to Canada and the Netherlands

    Quantity

    749 units