BEUDAMED
    FDA Recall Terminated

    Right Heart Catheter Product Line: Catalog Number 604264-------------427D1006I Round Molded Manifold.

    Recall: Z-1011-05 · Initiated May 25, 2005

    Recall

    Recall Number
    Z-1011-05
    Event Number
    32177
    Firm
    B. Braun Medical, Inc.
    FEI Number
    2523676
    Product Code
    DYG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 25, 2005
    Posted
    July 16, 2005
    Terminated
    December 14, 2006
    Address
    901 Marcon Blvd, Allentown, PA, 18109-9512

    Description

    Right Heart Catheter Product Line: Catalog Number 604264-------------427D1006I Round Molded Manifold.

    Reason

    Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs.

    Action

    The firm sent out recall notification letters to the Directors of Materials Management on 5/27/2005.

    Distribution

    Product was distributed to distributors and hospitals nationwide. Also, the products were distributed to Germany and Japan.

    Quantity

    468 units