BEUDAMED
    FDA Enforcement Class II Terminated

    Pinnacle¿ Destination¿ Peripheral Guiding Sheath, 8 French, 90cm, Straight Tip, Cross Cut Valve. Acts as a conduit to facilitate the introduction of interventional and diagnostic devices into the human vasculature.

    Recall: Z-1611-2013 · Reported July 3, 2013

    Enforcement

    Recall Number
    Z-1611-2013
    Event ID
    65397
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Terumo Medical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 3, 2013
    Initiation Date
    May 30, 2013
    Classification Date
    June 27, 2013
    Termination Date
    October 30, 2013
    Address
    950 Elkton Blvd, Elkton, MD, 21921-5322, United States

    Description

    Pinnacle¿ Destination¿ Peripheral Guiding Sheath, 8 French, 90cm, Straight Tip, Cross Cut Valve. Acts as a conduit to facilitate the introduction of interventional and diagnostic devices into the human vasculature.

    Reason

    Medical devices were incorrectly labeled with extended expiration dates.

    Code Info

    Lot MM27

    Distribution

    Nationwide Distribution.

    Quantity

    20 units