BEUDAMED
    FDA Recall Terminated

    Stryker SmartPump Extension Tubing (Pneumatic tourniquet). Sterile tubing extension 40" and 60", set, luer lock. Rx only. Stryker Instruments Div. of Stryker Corporation. Optional accessories used with the Stryker SmartPump Tourniquet System. The luer locks are intended to be connected to the tourniquet pump - to fill the line - and to the cuff. The extension tubing is an optional accessory used to connect the tourniquet cuff with the pump when a longer distance between the pump and the tourniquet is desired. The extension tubing comes packaged 10 per box.

    Recall: Z-3274-2011 · Initiated August 25, 2011

    Recall

    Recall Number
    Z-3274-2011
    Event Number
    59791
    Firm
    Stryker Instruments Div. of Stryker Corporation
    FEI Number
    1811755
    Product Code
    KCY
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    August 25, 2011
    Posted
    September 21, 2011
    Terminated
    October 12, 2011
    Address
    4100 E Milham Ave, Portage, MI, 49002-9704

    Description

    Stryker SmartPump Extension Tubing (Pneumatic tourniquet). Sterile tubing extension 40" and 60", set, luer lock. Rx only. Stryker Instruments Div. of Stryker Corporation. Optional accessories used with the Stryker SmartPump Tourniquet System. The luer locks are intended to be connected to the tourniquet pump - to fill the line - and to the cuff. The extension tubing is an optional accessory used to connect the tourniquet cuff with the pump when a longer distance between the pump and the tourniquet is desired. The extension tubing comes packaged 10 per box.

    Reason

    Three complaints have been reported indicating that the product inside the package did not match the label description. The units had quick connectors instead of luer lock connectors as stated in the label description.

    Action

    Stryker Instruments sent out "Urgent Medical Device Recall" notices dated August 22, 2011 to all affected customers. The letter included the name of the recalled product, lot numbers, and the reason for the recall. Customers were instructed to send back any product to Stryker that is within the affected lots. The letter further stated Stryker will quarantine the product and replace any product that is returned. For information on this recall contact Stryker Instruments at (269) 389-4534.

    Distribution

    Worldwide Distribution: Nationwide Distribution including the states of HAWAII, NORTH DAKOTA, NEBRASKA, PENNSYLVANIA, and IOWA, and the country of FRANCE

    Quantity

    5920-000-003 (30 bx) and 5920-000-005 (30 bx)