BEUDAMED
    FDA Enforcement Class II Terminated

    Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 1PRT(Single Port) Quick Connect Connector, Product Number 5921-018-135 - Product Usage: The Stryker Disposable Tourniquet Cuff (cuff) is indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patients extremities during surgical procedures to produce greater visualization of the operative field.

    Recall: Z-0592-2020 · Reported December 11, 2019

    Enforcement

    Recall Number
    Z-0592-2020
    Event ID
    84316
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Instruments Div. of Stryker Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 11, 2019
    Initiation Date
    November 6, 2019
    Classification Date
    December 2, 2019
    Termination Date
    November 19, 2021
    Address
    4100 E Milham Ave, Portage, MI, 49002-9704, United States

    Description

    Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 1PRT(Single Port) Quick Connect Connector, Product Number 5921-018-135 - Product Usage: The Stryker Disposable Tourniquet Cuff (cuff) is indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patients extremities during surgical procedures to produce greater visualization of the operative field.

    Reason

    There is a potential for the cuff to leak air leading to a loss of vascular occlusion.

    Code Info

    GTIN: 37613154599258, Lot Numbers 60180348, 60180373

    Distribution

    Worldwide distributions - US Nationwide distributions in the states of AL, CD, HI, IA, ID, IN, KS, KY, MA, ME, MI, MN, MT, NC, NE, NH, NJ, NV, NY, OK, OR, PA, SC, SD, TN, VA, WI, WV, and WY. Countries of Argentina, Australia, Canada, and Netherlands.

    Quantity

    16,380 total