BEUDAMED
    FDA Recall Terminated

    Medtronic 2T10R1 Intersept Custom Tubing Pack. Pack 2T10R1 consists of two PVC lines; one of them is 132 inch in length and is capped. The second line is 102 inch in length and has a one way vacuum relief valve assembled in one end. Tubing is used in the vent roller heads of the heart lung machine. This tubing is connected to the cannula in the patient in order to divert blood to the circuit when the patient is on bypass.

    Recall: Z-0583-2007 · Initiated January 2, 2007

    Recall

    Recall Number
    Z-0583-2007
    Event Number
    37079
    Firm
    Medtronic Perfusion Systems
    FEI Number
    1000116158
    Product Code
    DWE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 2, 2007
    Posted
    March 8, 2007
    Terminated
    February 24, 2008
    Address
    7611 Northland Dr N, Brooklyn Park, MN, 55428-1088

    Description

    Medtronic 2T10R1 Intersept Custom Tubing Pack. Pack 2T10R1 consists of two PVC lines; one of them is 132 inch in length and is capped. The second line is 102 inch in length and has a one way vacuum relief valve assembled in one end. Tubing is used in the vent roller heads of the heart lung machine. This tubing is connected to the cannula in the patient in order to divert blood to the circuit when the patient is on bypass.

    Reason

    One lot of Custom Perfusion Sets, Catalog 2T10R1 was incorrectly assembled. The one way vacuum relief valve on the 102 inch line is attached backwards, thus preventing flow.

    Action

    There was only one customer. The customer was sent a letter on December 29, 2006, requesting that the impacted product be disposed of or returned to Medtronic for disposal.

    Distribution

    Illinois

    Quantity

    17