BEUDAMED
    FDA Enforcement Class II Terminated

    Zimmer Tourniquet Cuff 30" (Blue), PLC Dual Port, Single Bladder, Item Number: 60-7070-105, UDI: 00885825013868, Reprocessed Tourniquet Cuff - Product Usage: Reprocessed tourniquet cuffs are indicated for use in patients who require surgery of the extremities with an expected duration of less than 90 minutes when temporary exsanguination of a limb is desired.

    Recall: Z-1802-2020 · Reported May 6, 2020

    Enforcement

    Recall Number
    Z-1802-2020
    Event ID
    85330
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Sustainability Solutions
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 6, 2020
    Initiation Date
    October 9, 2019
    Classification Date
    April 27, 2020
    Termination Date
    January 14, 2021
    Address
    1810 W Drake Dr, N/A, Tempe, AZ, 85283-4327, United States

    Description

    Zimmer Tourniquet Cuff 30" (Blue), PLC Dual Port, Single Bladder, Item Number: 60-7070-105, UDI: 00885825013868, Reprocessed Tourniquet Cuff - Product Usage: Reprocessed tourniquet cuffs are indicated for use in patients who require surgery of the extremities with an expected duration of less than 90 minutes when temporary exsanguination of a limb is desired.

    Reason

    Tourniquet cuffs are potentially mislabeled. If used may lead to (1) Device misuse during procedure (2) Inadequate Limb Compression Force.

    Code Info

    Lot Number 10237165

    Distribution

    US Nationwide distribution including the states of SC, TX, UT, NY, AR

    Quantity

    90