BEUDAMED
    FDA Recall Terminated

    Thermodilution Right Heart Catheters, Catalog Numbers 604028 and 604165. The product is shipped 5 units per carton.-B. Braun Medical, Allentown, Pa.

    Recall: Z-1116-2007 · Initiated June 5, 2007

    Recall

    Recall Number
    Z-1116-2007
    Event Number
    38105
    Firm
    B. Braun Medical, Inc.
    FEI Number
    2523676
    Product Code
    DYG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 5, 2007
    Posted
    July 23, 2007
    Terminated
    October 31, 2007
    Address
    901 Marcon Boulevard, Allentown, PA, 18109-9512

    Description

    Thermodilution Right Heart Catheters, Catalog Numbers 604028 and 604165. The product is shipped 5 units per carton.-B. Braun Medical, Allentown, Pa.

    Reason

    Cracks at the Catheter Tip

    Action

    On 6/5/07, a Product Removal Notice was issued to the only distributor that received the product in Japan

    Distribution

    International ONLY- Japan

    Quantity

    4,695