BEUDAMED
    FDA Recall Terminated

    AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-10F-45/80. Product is labeled as Sterile EO. Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The Delivery and Exchange Systems are placed onto polyboard backing cards. The backing card is then placed into a smaller of 2 Tyvek pouches. The pouch is then placed inside a larger Tyvek pouch. The kit is assembled at AGA and then sterilized by Steris, Minneapolis, MN.

    Recall: Z-0356-05 · Initiated November 23, 2004

    Recall

    Recall Number
    Z-0356-05
    Event Number
    30481
    Firm
    AGA Medical Corporation
    FEI Number
    3005334138
    Product Code
    BGK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 23, 2004
    Posted
    December 24, 2004
    Terminated
    December 26, 2006
    Address
    682 Mendelssohn Ave N, Golden Valley, MN, 55427-4306

    Description

    AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-10F-45/80. Product is labeled as Sterile EO. Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The Delivery and Exchange Systems are placed onto polyboard backing cards. The backing card is then placed into a smaller of 2 Tyvek pouches. The pouch is then placed inside a larger Tyvek pouch. The kit is assembled at AGA and then sterilized by Steris, Minneapolis, MN.

    Reason

    Tubing utilized in the manufacture of the AMPLATZER Delivery and Exchange System sheaths and dilators was in some cases manufactured by our supplier outside of process parameters; causing a residue to be left on the inside of the tubing.

    Action

    Recall notices were sent via e-mail 11/22/04 to physicians, hospitals and distributors who received affected product. Hard copies of the Recall Notices were sent to all customers (international and domestic) via Federal Express 11/22-24/04. A form that is attached to the Recall Notice asks for customers to fill out quantities of affected product and to return the affected product to AGA Medical.

    Distribution

    Product has been distributed throughout the US and Internationally, including Canada, Europe and Australia.

    Quantity

    9486