BEUDAMED
    FDA Enforcement Class II Ongoing

    Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1 BLA,1PRT QUICK Catalog number: 5921-218-135NS

    Recall: Z-1343-2023 · Reported April 12, 2023

    Enforcement

    Recall Number
    Z-1343-2023
    Event ID
    91849
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Stryker Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 12, 2023
    Initiation Date
    March 1, 2023
    Classification Date
    April 4, 2023
    Address
    1941 Stryker Way, Portage, MI, 49002-9711, United States

    Description

    Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1 BLA,1PRT QUICK Catalog number: 5921-218-135NS

    Reason

    Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cuff onto the patient, may lead to operative site blood loss, hemorrhage or, in exceedingly rare situations, other major complications

    Code Info

    GTIN: 07613327606133 Lot Numbers: 2022111801 2022112903 2022121201 2022121202 2022121203 2022121204 2022121205 2022121206

    Distribution

    US Nationwide distribution.

    Quantity

    1730 units (packs of 10)