BEUDAMED
    FDA Enforcement Class II Terminated

    Zimmer Sterile Disposable Tourniquet Cuff with Protective Sleeve and PLC, Dual Port, Dual Bladder, Item No. 60708015200, UDI (01)00889024377547 (17)230812(10)27968701 The product is a tourniquet - Product Usage: 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.

    Recall: Z-1356-2020 · Reported March 4, 2020

    Enforcement

    Recall Number
    Z-1356-2020
    Event ID
    84752
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Surgical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 4, 2020
    Initiation Date
    January 3, 2020
    Classification Date
    February 25, 2020
    Termination Date
    October 30, 2020
    Address
    200 W Ohio Ave, N/A, Dover, OH, 44622-9642, United States

    Description

    Zimmer Sterile Disposable Tourniquet Cuff with Protective Sleeve and PLC, Dual Port, Dual Bladder, Item No. 60708015200, UDI (01)00889024377547 (17)230812(10)27968701 The product is a tourniquet - Product Usage: 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.

    Reason

    When inflating/deflating a single bladder, both bladders could potentially inflate/deflate due to a leak between the bladders.

    Code Info

    Lot 27968701

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of CA, FL, IA, ID, IL, LA, MA, MO, NC, NY, OH, OR, PA, SC, TN, TX, WA, WI, and WV and country of Netherlands.

    Quantity

    58