BEUDAMED
    FDA Recall Terminated

    Celsite Implantable Access Port System, model ST301. The Celsite Implantable Access Port Systems (Celsite port systems) are implantable port and catheter systems that allow safe, repeated access to the patient's bloodstream. The port chamber and catheter design can be used for the administration of medication and fluids. The Celsite system consists of an access port with a silicone septum, which is connected to a catheter using a connection ring. The triangular shaped access port has a low profile nose, finger stops on the side of the housing, and a round base. Celsite access ports have suture holes or suture zones to secure placement during implantation.

    Recall: Z-2382-2015 · Initiated June 16, 2015

    Recall

    Recall Number
    Z-2382-2015
    Event Number
    71666
    Firm
    B. Braun Interventional Systems
    FEI Number
    3006332832
    Product Code
    LJT
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    June 16, 2015
    Posted
    August 13, 2015
    Terminated
    November 20, 2015
    Address
    3050 Ranchview Ln N, Minneapolis, MN, 55447-1459

    Description

    Celsite Implantable Access Port System, model ST301. The Celsite Implantable Access Port Systems (Celsite port systems) are implantable port and catheter systems that allow safe, repeated access to the patient's bloodstream. The port chamber and catheter design can be used for the administration of medication and fluids. The Celsite system consists of an access port with a silicone septum, which is connected to a catheter using a connection ring. The triangular shaped access port has a low profile nose, finger stops on the side of the housing, and a round base. Celsite access ports have suture holes or suture zones to secure placement during implantation.

    Reason

    The manufacturer, B. Braun medical France, received endotoxin test results that are out of specification for the peelable sheath (A1537).

    Action

    An Urgent Medical Device Recall letter, dated 6/16/2015 was sent to the 2 consignees via express mail. The letter explained the issue and requested the hospital review their inventory for the affected model and lot. If any quantities of the lot remained in inventory, the product was to be returned to BIS. A BIS sales representative will personally visit each account and complete an inventory sheet. Customers with questions can contact Paul O-Connell, President at 1-847-274-0097

    Distribution

    CA and NY only.

    Quantity

    11 units