BEUDAMED
    FDA Recall Terminated

    10.5 Fr. Percor STAT-DL intra-Aortic Balloon Catheter Insertion Kits which contain a Datascope 11.5 Fr. 11'' introducer sheaths. These introducer sheaths include a hemostasis valve and a hub which work in conjunction with an introducer dilator. The introducer sheath, after it is dilated by the introducer dilator, is intended to assist the percutaneous insertion of the 10.5 Fr. Intra-Aortic Balloon catheter into the vasculature.

    Recall: Z-0916-03 · Initiated March 21, 2003

    Recall

    Recall Number
    Z-0916-03
    Event Number
    25995
    Firm
    Datascope Corp
    FEI Number
    1000222374
    Product Code
    DSP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 21, 2003
    Posted
    June 5, 2003
    Terminated
    August 1, 2003
    Address
    15 Law Drive, Fairfield, NJ, 07004-3206

    Description

    10.5 Fr. Percor STAT-DL intra-Aortic Balloon Catheter Insertion Kits which contain a Datascope 11.5 Fr. 11'' introducer sheaths. These introducer sheaths include a hemostasis valve and a hub which work in conjunction with an introducer dilator. The introducer sheath, after it is dilated by the introducer dilator, is intended to assist the percutaneous insertion of the 10.5 Fr. Intra-Aortic Balloon catheter into the vasculature.

    Reason

    10.5 Fr. Percor STAT-DL Intra-Aortic Balloon Insertion Kit, Introducer Sheath failed water leak test during final inspection.

    Action

    Recall letters were sent via US mail return receipt requested to customers on 3/31/2003. Sales representatives received a letter on 3/28/2003.

    Distribution

    Product was distributed domestically to hospitals nationwide. There are no US government or foreign consignees.

    Quantity

    60 units