BEUDAMED
    FDA Recall Terminated

    Stryker Color Cuff, REF 5921-034-135 Disposable Tourniquet Cuffs 34 in x 4 in (86 cm x 10 cm) Single Bladder, Single Port, QuickConnect Rx only, STERILE

    Recall: Z-0630-2014 · Initiated December 6, 2013

    Recall

    Recall Number
    Z-0630-2014
    Event Number
    67040
    Firm
    Stryker Instruments Div. of Stryker Corporation
    FEI Number
    1811755
    Product Code
    KCY
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    December 6, 2013
    Posted
    January 6, 2014
    Terminated
    February 27, 2014
    Address
    4100 E Milham Ave, Portage, MI, 49002-9704

    Description

    Stryker Color Cuff, REF 5921-034-135 Disposable Tourniquet Cuffs 34 in x 4 in (86 cm x 10 cm) Single Bladder, Single Port, QuickConnect Rx only, STERILE

    Reason

    The Color Cuff Sterile Disposable Tourniquet Cuffs with Quick-Connect Fitting may have an incorrect end-connector. A customer reported having received a luer connector instead of a quick connect fitting. An incorrect connector may lead to an inoperable system due to incompatibility with the Smart Pump.

    Action

    Distributor was notified by E-mail 11/26/2013, with follow-up UPS letters sent to Hospital Risk/ Materials Managers identifying the product, reason for the recall, and risk. The notice asked consignees to find and quarantine all implicated product, with hospitals requested to complete the Business Reply Form and FAX to 866-521-2762. Stryker will email a pre-paid shipper and credit all accounts. Question and concerns should be addressed to Kelly Jo Whipple 269-389-2921 or [email protected]

    Distribution

    US Distribution: including states of: MI, OH, and TX.

    Quantity

    5 boxes (50 units)