BEUDAMED
    FDA Recall Terminated

    Medtronic Custom Packs and Total System Packs. Pack can contain a number of different components specified by the customer and individualized for their bypass circuit set up requirements. Intersept Custom Tubing Pack, Sterile and nonpyrogenic Fluid Path: Do not use if package is opened or damaged. For Single Use Only. Manufacturer: Medtronic , Inc. Minneapolis, MN 55432-5604 USA

    Recall: Z-0808-05 · Initiated March 25, 2005

    Recall

    Recall Number
    Z-0808-05
    Event Number
    31477
    Firm
    Medtronic Perfusion Systems
    FEI Number
    1000116158
    Product Code
    DWE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 25, 2005
    Posted
    May 10, 2005
    Terminated
    November 17, 2005
    Address
    7611 Northland Dr N, Brooklyn Park, MN, 55428-1088

    Description

    Medtronic Custom Packs and Total System Packs. Pack can contain a number of different components specified by the customer and individualized for their bypass circuit set up requirements. Intersept Custom Tubing Pack, Sterile and nonpyrogenic Fluid Path: Do not use if package is opened or damaged. For Single Use Only. Manufacturer: Medtronic , Inc. Minneapolis, MN 55432-5604 USA

    Reason

    Some warehouse inventory of Custom Pack product bags were found with ruptured seals. The seals were partially opened in the center of the bag's Tyvek edge. Since this bag is used to enclose and seal the custom pack assembly & had been sterilized, the ruptured seal breaches the sterility barrier for the package.

    Action

    US customers were sent certified letters beginning 03/25/05 identifying the situation, cautioning customers about the possibility of an open bag with loss of sterility and requested return of all product to Medtronic Perfusions Systems at 7611 Northland Blvd., Brooklyn Park, MN. Customers are also requested to complete a Field Corrective Action Certificate acknowledging the receipt of this information.

    Distribution

    nationwide, Canada, Australia, Japan and Latin America