BEUDAMED
    FDA Enforcement Class II Terminated

    Medtronic Perfusion Tubing Packs, Models TL7M64R3, TL7P17R1 & HY2W85R9, Sterilized using Ethylene Oxide. The Tubing Pack design and components are specified by the user, they are packaged with consideration of setup efficiency and respect for the environment, and they are intended for use in the extracorporeal circuit during cardiopulmonary bypass procedures. Medtronic Tubing Packs can contain components with Carmeda BioActive Surface, Trillium BioSurface, Balance BioSurface or no coating. Sterile barrier for these packs is provided either by a Tyvek lid seal on the tray or by a header bag.

    Recall: Z-0268-2016 · Reported November 18, 2015

    Enforcement

    Recall Number
    Z-0268-2016
    Event ID
    72550
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Perfusion Systems
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 18, 2015
    Initiation Date
    October 28, 2015
    Classification Date
    November 12, 2015
    Termination Date
    August 17, 2016
    Address
    7611 Northland Dr N, N/A, Brooklyn Park, MN, 55428-1088, United States

    Description

    Medtronic Perfusion Tubing Packs, Models TL7M64R3, TL7P17R1 & HY2W85R9, Sterilized using Ethylene Oxide. The Tubing Pack design and components are specified by the user, they are packaged with consideration of setup efficiency and respect for the environment, and they are intended for use in the extracorporeal circuit during cardiopulmonary bypass procedures. Medtronic Tubing Packs can contain components with Carmeda BioActive Surface, Trillium BioSurface, Balance BioSurface or no coating. Sterile barrier for these packs is provided either by a Tyvek lid seal on the tray or by a header bag.

    Reason

    This recall is being initiated due to a potential breach of the Tubing Pack Header Bags manufactured in these select lots. The seal in question is between the Tyvek and the Poly side of the header bag.

    Code Info

    Model Lot Numbers Lot Number HY2W85R9 209704344,209704345,209704346, 209704347,210010558 TL7M64R3 209789393 TL7P17R1 209789333

    Distribution

    Nationwide Distribution including US: AL, IL, IN, and WI.

    Quantity

    496