BEUDAMED
    FDA Enforcement Class II 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 · Reported January 15, 2014

    Enforcement

    Recall Number
    Z-0630-2014
    Event ID
    67040
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Instruments Div. of Stryker Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    January 15, 2014
    Initiation Date
    December 6, 2013
    Classification Date
    January 6, 2014
    Termination Date
    February 27, 2014
    Address
    4100 E Milham Ave, Portage, MI, 49002-9704, United States

    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.

    Code Info

    Lot 50731155 Color code Purple

    Distribution

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

    Quantity

    5 boxes (50 units)