BEUDAMED
    FDA Recall Terminated

    B. Braun Celsite Venous Access Ports , Distributed by Aesculpa Inc. Model ST301, ST305V, ST301G, ST501G and ST315 Reference # Model # 04430425 ST301 04430095 ST305V 04433823 ST301G 04437025 ST501G 04436725 ST315

    Recall: Z-2671-2011 · Initiated April 13, 2011

    Recall

    Recall Number
    Z-2671-2011
    Event Number
    58718
    Firm
    B. Braun Interventional Systems
    FEI Number
    3006332832
    Product Code
    LJT
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    April 13, 2011
    Posted
    June 27, 2011
    Terminated
    July 6, 2012
    Address
    14276 23rd Ave N, Plymouth, MN, 55447-4910

    Description

    B. Braun Celsite Venous Access Ports , Distributed by Aesculpa Inc. Model ST301, ST305V, ST301G, ST501G and ST315 Reference # Model # 04430425 ST301 04430095 ST305V 04433823 ST301G 04437025 ST501G 04436725 ST315

    Reason

    The affected products contain the incorrect winged Surecan needle accessory component in certain Celsite Access Port package configurations. The winged Surecan needle is used to deliver medications and fluids into implanted Celsite Access Ports. Two winged Surecan needle sizes are provided in Celsite U.S. package configurations: 20G (PN 4058631) or 22G (PN 16006593A). A 20G or 22G needle

    Action

    B.Braun Interventional Systems Inc, (BIS) sent a "Urgent Medical Device Recall" letter on April 16, 2011 to all affected customers. The letter described the problem and the product involved in the recall. Informed consignees that their local B.Braun Interventional System Inc Product Specialists will contact them with the specifics for return/replacement of the product upon return of qualified removed product. They also requested that a Celsite Access Port Patient Implant Form be filled out for each patient implanted with one of the Celsite Access Ports from the affected lots. This Form to be provided to them by their local BIS Product Specialist. For additional information contact 800 523-9676 x4459.

    Distribution

    NY, ND, OK ,PA

    Quantity

    83