Events

Recall of Device Recall Celsite Access Port

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by B. Braun Interventional Systems.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    52611
  • Event Risk Class
    Class 2
  • Event Number
    Z-1961-2009
  • Event Initiated Date
    2009-06-22
  • Event Date Posted
    2009-09-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83457
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
  • 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.

Device

Device Recall Celsite Access Port
  • Model / Serial
    Lot Numbers: H3238310 and I0059950.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution -- NY.
  • Product 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.
  • Manufacturer
    B. Braun Interventional Systems

Manufacturer

B. Braun Interventional Systems
  • Manufacturer Address
    B. Braun Interventional Systems, 14276 23rd Ave N, Plymouth MN 55447-4910
  • Manufacturer Parent Company (2017)
    Ludwig G. Braun Gmbh U. Co. Kg
  • Source
    USFDA