BEUDAMED
    FDA Recall Terminated

    Celsite Access Port Model ST305P. The Celsite Access Port model ST305P is a member of the Celsite product line of implantable port and catheter systems.

    Recall: Z-1961-2009 · Initiated June 22, 2009

    Recall

    Recall Number
    Z-1961-2009
    Event Number
    52611
    Firm
    B. Braun Interventional Systems
    FEI Number
    3006332832
    Product Code
    LJT
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 22, 2009
    Posted
    September 3, 2009
    Terminated
    June 5, 2012
    Address
    14276 23rd Ave N, Plymouth, MN, 55447-4910

    Description

    Celsite Access Port Model ST305P. The Celsite Access Port model ST305P is a member of the Celsite product line of implantable port and catheter systems.

    Reason

    B. Braun Interventional Systems was notified by B. Braun Medical France, the manufacturer of the Celsite Access port that they had received 11 reports of polyurethane (type P) catheter disconnections. B. Braun Medical France has decided to recall all Celsite ports supplied with the affected catheter lot. To date, B. Braun Interventional Systems (US) has not received any reports of catheter dis

    Action

    B. Braun Interventional Systems, Inc. issued an "Urgent: Medical Device Recall" notice dated June 22, 2009. The letter identified the problem and product. The letter reminded the consignee of the general instruction for use of access ports and instructed them to contact patients who had the Celsite port system implanted. For further questions, contact B. Braun Interventional Systems, Inc. at 1-800-523-9676 extension 4818.

    Distribution

    Nationwide Distribution -- NY.

    Quantity

    40 in US