BEUDAMED
    FDA Recall Terminated

    Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.

    Recall: Z-0324-2017 · Initiated September 19, 2016

    Recall

    Recall Number
    Z-0324-2017
    Event Number
    75221
    Firm
    Stryker Sustainability Solutions
    FEI Number
    3009350690
    Product Code
    KCY
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 19, 2016
    Terminated
    June 1, 2017
    Address
    1810 W Drake Dr, Tempe, AZ, 85283-4327

    Description

    Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.

    Reason

    Issue with the process for detection of leaking Pressure Tourniquet Cuffs (PTC). Leaking PTC devices may result in excessive blood loss requiring surgical or medical intervention or systemic leakage of local anesthetic during Bier Block requiring medical intervention.

    Action

    Stryker Sustainability Solutions sent an Customer Notification letter September 19, 2016. Customers were instructed to discontinue use of the affected products. The letter stated to follow the link below to complete the Recall Effectiveness Check Form and indicate if any devices containing expiration dates from May 2016-May 2018 remain in inventory. This form must be completed even if no affected product is found. Use the following reference number as you complete the form: [Ship to Account #] If the form indicates that any affected devices remain in inventory, a prepaid shipping label will be issued for the return of the product. Credit for all affected devices returned will be issued to the facility. .Adverse reactions or quality problems experienced with the use of this product may be reported to: o Stryker Sustainability Solutions Complaint Hotline: +1(888) 888-3433 X5555 o http://www.stryker.com/productexperience/ o The FDAs MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

    Distribution

    U.S. distribution nationwide. No foreign distribution

    Quantity

    1,695,760