BEUDAMED
    FDA Recall 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 · Initiated January 3, 2020

    Recall

    Recall Number
    Z-1356-2020
    Event Number
    84752
    Firm
    Zimmer Surgical Inc
    FEI Number
    1526350
    Product Code
    KCY
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 3, 2020
    Posted
    January 28, 2020
    Terminated
    October 30, 2020
    Address
    200 W Ohio Ave, Dover, OH, 44622-9642

    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.

    Action

    On January 3, 2020, the recalling firm distributed recall notices to affected customers via email and FedEx. Customers were instructed to ensure that affected personnel are aware of the contents, and assist the Zimmer Biomet sales representative to locate, quarantine, and return all affected product. If you have questions or concerns regarding this recall, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to [email protected].

    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