BEUDAMED
    FDA Recall Terminated

    Vaxcel Plus Chronic Dialysis Catheters - Catheter/CPU/15/37/Plastic Catalog Number : 45-553

    Recall: Z-1500-05 · Initiated July 22, 2005

    Recall

    Recall Number
    Z-1500-05
    Event Number
    32694
    Firm
    Boston Scientific Corporation
    FEI Number
    3001451463
    Product Code
    KOB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 22, 2005
    Posted
    September 2, 2005
    Terminated
    June 20, 2007
    Address
    1 Boston Scientific Pl, Natick, MA, 01760-1536

    Description

    Vaxcel Plus Chronic Dialysis Catheters - Catheter/CPU/15/37/Plastic Catalog Number : 45-553

    Reason

    The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.

    Action

    Boston Scientific intiated the recall on 7/22/05 to direct accounts and to distributors on 7/ 27 /05. Distributors are requested to conduct sub recalls to the medical facility level. A revised letter dated 8/2/05 was sent to 18 US accounts for one lot (#1020895) omitted in the letter of 7/22/05.

    Distribution

    Nationwide VA Hopsitals Foreign: Canada, Africa, Japan, Israel, Japan, Nertherlands, Venezula