BEUDAMED
    FDA Recall Terminated

    Pinnacle Destination Guiding Sheath, 6 French, 90 cm, Straight Tip, Tuohy-Borst Valve, Lot MD24, MD31, ME07, & ME14. 510(k) K012812 Guiding Sheath is used to facilitate the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal arteries for the Renal Guiding Sheath and the carotid arteries for the Carotid Guiding Sheath.

    Recall: Z-2415-2011 · Initiated June 24, 2010

    Recall

    Recall Number
    Z-2415-2011
    Event Number
    58677
    Firm
    Terumo Medical Corporation
    FEI Number
    1118880
    Product Code
    DYB
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    June 24, 2010
    Posted
    June 6, 2011
    Terminated
    July 7, 2011
    Address
    950 Elkton Blvd, Elkton, MD, 21921-5322

    Description

    Pinnacle Destination Guiding Sheath, 6 French, 90 cm, Straight Tip, Tuohy-Borst Valve, Lot MD24, MD31, ME07, & ME14. 510(k) K012812 Guiding Sheath is used to facilitate the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal arteries for the Renal Guiding Sheath and the carotid arteries for the Carotid Guiding Sheath.

    Reason

    Molding defect in destination product that render the device unusable.

    Action

    Terumo Medical Corporation sent an Urgent Product Bulletin Recall letter dated June 24, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Terumo requested customers to immediately discontinue use, and quarantine any available stock of the listed product codes. In order to facilitate the exchange of these devices, a Terumo Territory Manager contacted all customers by July 9th to confirm receipt of the Terumo Destination Bulletin and scheduled an appointment to visit each customer in person by July 31st to personally manage the exchange. For questions or for further information, call (800) 283-7866 and ask to speak with the Product Recall Coordinator.

    Distribution

    Worldwide Distribution - USA including AL, AK, AZ, TX, LA, MS, MN, MO, CA, GA, FL, HI, KS, IA, ID, IL, TN, NM, OR, OK, WA, and WI and the countries of Belgium, Brazil, and Panama

    Quantity

    214 units