Recall of B.Braun Celsite

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    Intravascular access port - Product Code LJT
  • 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.


  • Model / Serial
    Reference # Model # Lot # 04430425 ST301 J313196U 04430095 ST305V J312177U 04433823 ST301G J313197U  K021193U 04437025 ST501G J312178U 04436725 ST315 J295789U
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    NY, ND, OK ,PA
  • Product 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
  • Manufacturer


  • Manufacturer Address
    B. Braun Interventional Systems, 14276 23rd Ave N, Plymouth MN 55447-4910
  • Manufacturer Parent Company (2017)
  • Source