BEUDAMED
    FDA Recall Terminated

    VAXCEL MINI-STICK COAXIAL DILATOR SET. Each kit contains a radiopaque Coaxial Dilator (5 Fr), a 21 Ga. echogenic entry needle, and a .018 in. / 0,46 mm guidewire with a floppy lip. Cat. #45-994. Firm on the label: Boston Scientific.

    Recall: Z-0760-04 · Initiated March 5, 2004

    Recall

    Recall Number
    Z-0760-04
    Event Number
    28533
    Firm
    Boston Scientific Corporation
    FEI Number
    3001451463
    Product Code
    DRE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 5, 2004
    Posted
    July 20, 2004
    Terminated
    October 26, 2005
    Address
    1 Boston Scientific Pl, Natick, MA, 01760-1536

    Description

    VAXCEL MINI-STICK COAXIAL DILATOR SET. Each kit contains a radiopaque Coaxial Dilator (5 Fr), a 21 Ga. echogenic entry needle, and a .018 in. / 0,46 mm guidewire with a floppy lip. Cat. #45-994. Firm on the label: Boston Scientific.

    Reason

    Kits containing 5 Fr dilators may be labeled as 4 Fr. Kits containing 4 Fr dilators may be labeled as 5 Fr.

    Action

    Letter dated 3/5/04 with instructions to return product.

    Distribution

    42 domestic hospitals nationwide and one distributor in Canada.

    Quantity

    100 units (box/10)