BEUDAMED
    FDA Recall Terminated

    Medtronic Intersept Custom Tubing Pack. Do Not Reuse. The design and components of this product were specified by the user from an array of components and designs offered by the manufacturer. Any change in the cardiopulmonary bypass procedure that compromises the function of this Custom Tubing Pack is the responsibility of the user. The tubing is made of polyvinyl chloride (PVC). Portions of the tapered tubing are used in the vent, suction and arterial roller heads of the heart lung machine. Manufacturer: Medtronic, Inc., Minneapolis, MN 55432-5604 USA. Tube supplier: Natvar (Tekni-Plex Co.), 19555 E. Arenth Ave., City of Industry, CA 91748.

    Recall: Z-0340-2007 · Initiated September 13, 2006

    Recall

    Recall Number
    Z-0340-2007
    Event Number
    36333
    Firm
    Medtronic Perfusion Systems
    FEI Number
    1000116158
    Product Code
    DWE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 13, 2006
    Posted
    January 25, 2007
    Terminated
    February 3, 2007
    Address
    7611 Northland Dr N, Brooklyn Park, MN, 55428-1088

    Description

    Medtronic Intersept Custom Tubing Pack. Do Not Reuse. The design and components of this product were specified by the user from an array of components and designs offered by the manufacturer. Any change in the cardiopulmonary bypass procedure that compromises the function of this Custom Tubing Pack is the responsibility of the user. The tubing is made of polyvinyl chloride (PVC). Portions of the tapered tubing are used in the vent, suction and arterial roller heads of the heart lung machine. Manufacturer: Medtronic, Inc., Minneapolis, MN 55432-5604 USA. Tube supplier: Natvar (Tekni-Plex Co.), 19555 E. Arenth Ave., City of Industry, CA 91748.

    Reason

    An out of specification condition exists with the tapered tubing found in some Custom Tubing Packs. The wall thickness is undersized and does not meet specifications.

    Action

    An Important Customer Notification, dated 09/06/06, was sent to affected customers. The letter identifies the affected model and lot numbers. Medtronic requests that affected product be returned. A suplemental pack can be built and shipped to the customer upon request. Medtronic will replace all returned product. A Recall Certificate is asked to be completed by customer and faxed to Medtronic.

    Distribution

    Distributed in 6 states: CA, FL, IL, IN, LA and TN

    Quantity

    146