BEUDAMED
    FDA Recall Terminated

    Reprocessed Stryker Color Cuff and Color Cuff II Adult Tourniquet Cuffs Model Numbers: 5921-218-135, 5921-044-135, 5921-034-135, 5921-034-235, 5921-024-236 Indicated for use in patients who require surgery of the extremities.

    Recall: Z-0629-2016 · Initiated December 17, 2015

    Recall

    Recall Number
    Z-0629-2016
    Event Number
    72880
    Firm
    Stryker Sustainability Solutions
    FEI Number
    3009350690
    Product Code
    KCY
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    December 17, 2015
    Posted
    January 12, 2016
    Terminated
    July 14, 2016
    Address
    1810 W Drake Dr, Tempe, AZ, 85283-4327

    Description

    Reprocessed Stryker Color Cuff and Color Cuff II Adult Tourniquet Cuffs Model Numbers: 5921-218-135, 5921-044-135, 5921-034-135, 5921-034-235, 5921-024-236 Indicated for use in patients who require surgery of the extremities.

    Reason

    Reprocessed Stryker Pressure Tourniquet Cuffs were mislabeled, including some labeled as single port when they contained dual port, and vice versa.

    Action

    The firm sent out customer notification letters on 12/17/15. The firm requests that customers discontinue the use of the affected lots of the recall product, and other Pressure Tourniquet Cuffs reprocessed by Stryker Sustainability Solutions should be considered as alternatives. A Recall Effectiveness Check Form including the quantity of affected devices shipped to the customer is included with the notification. The firm states to complete the Recall Effectiveness Check Form and indicate if any devices from the affected lots remain in inventory. The letter states the form needs to be completed even if no product is found. If the form indicates that affected devices remain in inventory, a prepaid shipping label will be issued for the return of the product. Customers will receive a credit for all affected devices returned. Adverse reactions or quality problems experienced with the use of this product may be reported to: - Stryker Sustainability Solutions Complaint Hotline: +1(888) 888-3433X5555 - http://www.stryker.com/productexperience/ - The FDAs MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

    Distribution

    Nationwide Distribution including the states of AK, NV, VT, FL, CA, CO, WI, IA, MN, OK, PA, MI, OR, KY, and MA.

    Quantity

    450 devices