BEUDAMED
    FDA Enforcement Class II Terminated

    Medtronic Custom Perfusion System. Model Numbers: 1D80R8, 1E34R1, 1F75R1, 1G49R2, 1G75R1, 1P07R8, 1P91R4, 5B15R11, and 5P51R9. Sterilized by Ethylene Oxide, Do no Reuse. Product Usage: This product is indicated for use in the extracorporeal circuit during cardiopulmonary surgery.

    Recall: Z-2104-2013 · Reported September 4, 2013

    Enforcement

    Recall Number
    Z-2104-2013
    Event ID
    65831
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Inc. Cardiac Rhythm Disease Management
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 4, 2013
    Initiation Date
    July 17, 2013
    Classification Date
    August 27, 2013
    Termination Date
    February 4, 2014
    Address
    8200 Coral Sea St NE, Saint Paul, MN, 55112-4391, United States

    Description

    Medtronic Custom Perfusion System. Model Numbers: 1D80R8, 1E34R1, 1F75R1, 1G49R2, 1G75R1, 1P07R8, 1P91R4, 5B15R11, and 5P51R9. Sterilized by Ethylene Oxide, Do no Reuse. Product Usage: This product is indicated for use in the extracorporeal circuit during cardiopulmonary surgery.

    Reason

    Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suction Wand, model S099B. The Wands are included within certain Perfusion Tubing Packs that are manufactured and distributed by Medtronic.

    Code Info

    Lot: 11110924, 11178379, 11281864, 11341336, 11346822, 11357000, 11386060, 11387461, 11412023, 11448066, 11501190, 11506220, 11506223, 11528161, 11552139, 11577959, 11600953, 11623004, 11664710, 11672387, 11718344, 11719034, 11736936, 11816427, 11839402, 11843611, 11869817, 11896503, 11930457, 11995799, 11995883, 12000022, 12024743, 12024776, 12075385, 12093515, 12096289, 12166420, 12249817, 12264661, 12309956, 12374421, 12411720, 206168235, 206219230, 206325047, 206388493, 206476804, 206581948, 206597875, 206689812, 206709358, 206720707, 206851972, 206852054, 206864691, 206904419, 206991490, 207003054, 207100337, and 207121513.

    Distribution

    Worldwide Distribution - USA Nationwide CA, IL, LA, MI and the country of CANADA

    Quantity

    13223