BEUDAMED
    FDA Recall Terminated

    NAMIC Custom Angiographic Kit, Left Heart Kit - . Model #H749651947220. Catalog # 65194722. Firm on kit label: Manufactured by: Boston Scientific Corporation/NAMIC Technology Center, Glens Falls, NY 12801.

    Recall: Z-0302-05 · Initiated October 21, 2004

    Recall

    Recall Number
    Z-0302-05
    Event Number
    30489
    Firm
    Boston Scientific Corp
    FEI Number
    3017892510
    Product Code
    FMI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 21, 2004
    Posted
    December 9, 2004
    Terminated
    October 13, 2005
    Address
    10 Glens Falls, Tech Park Glens Falls, NY, 12801-3864

    Description

    NAMIC Custom Angiographic Kit, Left Heart Kit - . Model #H749651947220. Catalog # 65194722. Firm on kit label: Manufactured by: Boston Scientific Corporation/NAMIC Technology Center, Glens Falls, NY 12801.

    Reason

    The kits contain defective Magellan Monoject Safety Needles. The needle shaft may separate from the hub. Tyco Healthcare has recalled the needles.

    Action

    Two customers contacted via phone on 10/21/04 and 10/22/04, followed by letters dated 11/17/2004. Customers instructed to discontinue use and return product. Distributor instructed to notify customers.

    Distribution

    2 customers in IL and NV.

    Quantity

    128 kits