BEUDAMED
    FDA Enforcement Class II Terminated

    St Jude Medical, 10F Fast-Cath Trio" Hemostasis Introducer, REF # 406308, Sterile EO. The Fast-Cath Trio" Hemostasis Introducer consists of the following components: Port hemostasis adapter (3), Sheath (10F Cath-Lock"), dilator (10F) and 0.038 guidewire. See product labeling for diagram of contents.

    Recall: Z-0108-2015 · Reported October 29, 2014

    Enforcement

    Recall Number
    Z-0108-2015
    Event ID
    69499
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    St Jude Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 29, 2014
    Initiation Date
    October 14, 2014
    Classification Date
    October 21, 2014
    Termination Date
    March 25, 2015
    Address
    1 Saint Jude Medical Dr, Saint Paul, MN, 55117-1789, United States

    Description

    St Jude Medical, 10F Fast-Cath Trio" Hemostasis Introducer, REF # 406308, Sterile EO. The Fast-Cath Trio" Hemostasis Introducer consists of the following components: Port hemostasis adapter (3), Sheath (10F Cath-Lock"), dilator (10F) and 0.038 guidewire. See product labeling for diagram of contents.

    Reason

    St. Jude Medical is conducting a voluntary recall of SMJ Batch # 4641580 of the Fast-Cath Trio" Hemostasis Introducer, Catalog number 406308. The inner diameter of the 10F dilator is too small, such that the guidewire cannot advance through the device which may result in a procedural delay while another dilator of the desired size is obtained.

    Code Info

    Batch 4641580

    Distribution

    Nationwide Distribution including FL, IN, ME, MA, NY, NY, OH, RI,TX, and WV.

    Quantity

    220