BEUDAMED
    FDA Recall Terminated

    Diapact CRRT Assembled Kit HF/HD with Manifold and Standard Spike, item number 7210513. The product is shipped 4 units per shipping carton. Hemodialysis kit, B. Braun Medical, Inc., Allentown, PA 18109

    Recall: Z-1035-2008 · Initiated December 10, 2007

    Recall

    Recall Number
    Z-1035-2008
    Event Number
    46348
    Firm
    B. Braun Medical, Inc.
    FEI Number
    2523676
    Product Code
    FJK
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 10, 2007
    Posted
    May 7, 2008
    Terminated
    October 28, 2008
    Address
    901 Marcon Boulevard, Allentown, PA, 18109-9512

    Description

    Diapact CRRT Assembled Kit HF/HD with Manifold and Standard Spike, item number 7210513. The product is shipped 4 units per shipping carton. Hemodialysis kit, B. Braun Medical, Inc., Allentown, PA 18109

    Reason

    Faulty tubing does not prime machine as intended.

    Action

    B. Braun Medical sent an Urgent Medical Device Reall letter dated 12/12/07. Customers were told to discontinue use of the tubing.

    Distribution

    Nationwide Distribution.

    Quantity

    1544 units