BEUDAMED
    FDA Enforcement Class II Terminated

    30inch Dual Port/Single Bladder Disposable Tourniquet Cuff with PLC, Zimmer Surgical, Inc. Tourniquets are intended to be used by qualified medical professionals to exert enough pressure on the arterial blood flow in a limb to produce a bloodless operating field. Single bladder tourniquet cuffs are generally used for operations lasting less than 90 minutes.

    Recall: Z-2349-2015 · Reported August 12, 2015

    Enforcement

    Recall Number
    Z-2349-2015
    Event ID
    71575
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Surgical Inc
    Voluntary / Mandated
    N/A
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    August 12, 2015
    Initiation Date
    June 24, 2015
    Classification Date
    August 6, 2015
    Termination Date
    November 4, 2016
    Address
    200 W Ohio Ave, N/A, Dover, OH, 44622-9642, United States

    Description

    30inch Dual Port/Single Bladder Disposable Tourniquet Cuff with PLC, Zimmer Surgical, Inc. Tourniquets are intended to be used by qualified medical professionals to exert enough pressure on the arterial blood flow in a limb to produce a bloodless operating field. Single bladder tourniquet cuffs are generally used for operations lasting less than 90 minutes.

    Reason

    The inside of the folded Instructions For Use (IFU) pamphlet was missing the usage instructions and warnings.

    Code Info

    Item 60707010500, Lot Z000002535 & Item 60707010500, Lot Z000002541.

    Distribution

    Worldwide Distribution - US including AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV & WY and Internationally to Canada.

    Quantity

    330 units