BEUDAMED
    FDA Recall Terminated

    Medtronic Intersept 3608 Sterile tubing (8') 1/2 x 3/32 in. Quantity 10, Lot 7626621, Use by 2009-07-31. Manufacturer: Medtronic, Inc. Minneapolis, MN 55432-5604 USA. Different components and tubing sets are included within the Custom Pack depending on customer requirements. Tubing sets are placed within a plastic tray, which then is wrapped and placed inside a header bag and sealed at the plastic side. This bag seves as the product sterile barrier.

    Recall: Z-1227-2007 · Initiated August 1, 2007

    Recall

    Recall Number
    Z-1227-2007
    Event Number
    38485
    Firm
    Medtronic Perfusion Systems
    FEI Number
    1000116158
    Product Code
    DWE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 1, 2007
    Posted
    September 25, 2007
    Terminated
    October 10, 2008
    Address
    7611 Northland Dr N, Brooklyn Park, MN, 55428-1088

    Description

    Medtronic Intersept 3608 Sterile tubing (8') 1/2 x 3/32 in. Quantity 10, Lot 7626621, Use by 2009-07-31. Manufacturer: Medtronic, Inc. Minneapolis, MN 55432-5604 USA. Different components and tubing sets are included within the Custom Pack depending on customer requirements. Tubing sets are placed within a plastic tray, which then is wrapped and placed inside a header bag and sealed at the plastic side. This bag seves as the product sterile barrier.

    Reason

    Medtronic Custom Tubing Packs might have open header bag seals.

    Action

    Certified letters dated 8/1/07 were sent to customers. The letter explains the situation and requests the impacted product to be returned to Medtronic for replacement or credit. The customers are being requested to complete a Recall Certificate acknowledging the receipt of the information.

    Distribution

    Nationwide.

    Quantity

    853 packs