Events

Recall of Device Recall Celsite Implantable Access Port System

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
    71666
  • Event Risk Class
    Class 2
  • Event Number
    Z-2382-2015
  • Event Initiated Date
    2015-06-16
  • Event Date Posted
    2015-08-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-11-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138664
  • 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
    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

Device

Device Recall Celsite Implantable Access Port System
  • Model / Serial
    Lot number: 36896615
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    CA and NY only.
  • Product 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.
  • Manufacturer
    B. Braun Interventional Systems

Manufacturer

B. Braun Interventional Systems
  • Manufacturer Address
    B. Braun Interventional Systems, 3050 Ranchview Ln N, Minneapolis MN 55447-1459
  • Manufacturer Parent Company (2017)
    Ludwig G. Braun Gmbh U. Co. Kg
  • Source
    USFDA