BEUDAMED
    FDA Recall Terminated

    Heartport Direct Flow Arterial Cannula, product code DFK24. The device is sold separately and also in the following Kit Model Numbers: EDNN241, EDnn242, EDNN243, and EDNN244.

    Recall: Z-1101-06 · Initiated April 27, 2006

    Recall

    Recall Number
    Z-1101-06
    Event Number
    35335
    Firm
    Ethicon, Inc. US
    FEI Number
    2210968
    Product Code
    DWF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 27, 2006
    Posted
    June 9, 2006
    Terminated
    December 3, 2008
    Address
    Highway 22 West, Somerville, NJ, 08876

    Description

    Heartport Direct Flow Arterial Cannula, product code DFK24. The device is sold separately and also in the following Kit Model Numbers: EDNN241, EDnn242, EDNN243, and EDNN244.

    Reason

    During cardiopulmonary bypass (CPB) the distal tip of the arterial cannula can become disconnected from the body of the cannula.

    Action

    The recall was initiated on 4/27/2006. The hospitals were notified via letters to the Director of Material Management, Director of the OR as well as the Director of the Cardiovascular Suite in the US. The letters were sent via certified mail delivery. For international, notification was made to the J&J affiliates (Gargrave and Italy) by the European Authorized Representative. Each country will follow local procedures for notitying customers.

    Distribution

    There are 25 direct customers. There are no distributors, wholesalers and retailers. The firm ships direct to the medical facility. There are 11 International customers located in United Kingdom and Italy.

    Quantity

    368