BEUDAMED
    FDA Enforcement Class II Terminated

    Zimmer, Reprocessed Zimmer Tourniquet Cuffs,34" Single Hose Single Bladder Brown (PLC), 34", Model (Reprocessor) Number: ZIM60-7075-106, Reprocessed by Sterilmed. Products are individually packaged in a Tyvek¿/poly pouch. There are 5 pouches placed inside a casepack box. Each sales unit (casepack) contains 5 devices.

    Recall: Z-2819-2015 · Reported October 7, 2015

    Enforcement

    Recall Number
    Z-2819-2015
    Event ID
    72035
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    STERILMED, INC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 7, 2015
    Initiation Date
    August 24, 2015
    Classification Date
    September 28, 2015
    Termination Date
    March 11, 2016
    Address
    11400 73rd Ave N, N/A, Maple Grove, MN, 55369-5561, United States

    Description

    Zimmer, Reprocessed Zimmer Tourniquet Cuffs,34" Single Hose Single Bladder Brown (PLC), 34", Model (Reprocessor) Number: ZIM60-7075-106, Reprocessed by Sterilmed. Products are individually packaged in a Tyvek¿/poly pouch. There are 5 pouches placed inside a casepack box. Each sales unit (casepack) contains 5 devices.

    Reason

    Sterilmed, Inc. is recalling its reprocessed Zimmer Tourniquet Cuff, Part #ZIM60-7075-106, lot number 1846885 due to mislabeling. The affected reprocessed product is labeled as single hose devices but the devices inside the packaging are dual hose devices.

    Code Info

    Lot 1846885

    Distribution

    US Nationwide Distribution in the states of CA, KY, MI, OH, UT and WI.

    Quantity

    43