BEUDAMED
    FDA Recall Terminated

    Manual Biopsy Devices containing AIM system: Chiba Needle, 8 inch/20 cm, 22 gauge, Cat. #40-103, Material #M001401031 (10 per box). Firm on label: Boston Scientific / MEDI-TECH, 480 Pleasant Street, Watertown, MA 02472.

    Recall: Z-1443-04 · Initiated August 9, 2004

    Recall

    Recall Number
    Z-1443-04
    Event Number
    29795
    Firm
    Boston Scientific Corporation
    FEI Number
    3001451463
    Product Code
    KNW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 9, 2004
    Posted
    September 14, 2004
    Terminated
    October 26, 2005
    Address
    1 Boston Scientific Pl, Natick, MA, 01760-1536

    Description

    Manual Biopsy Devices containing AIM system: Chiba Needle, 8 inch/20 cm, 22 gauge, Cat. #40-103, Material #M001401031 (10 per box). Firm on label: Boston Scientific / MEDI-TECH, 480 Pleasant Street, Watertown, MA 02472.

    Reason

    Incomplete graduation on the needle guard, which would cause the graduations to be off by as much as 1 cm.

    Action

    Letters dated 8/9/04 hand delivered by Boston Scientific Sales Representatives. Sales Reps will visit each consignee and assist customers in locating affected units and will place a sticker label on each unit.

    Distribution

    Products sold to 53 medical facilities nationwide and one consignee in Italy.

    Quantity

    48 cartons x 10 units