Events

Recall of Device Recall BardPort M.R.I. Implanted Port

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bard Access 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
    61185
  • Event Risk Class
    Class 3
  • Event Number
    Z-1133-2012
  • Event Initiated Date
    2012-02-16
  • Event Date Posted
    2012-03-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107495
  • 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 end flap label on the kit incorrectly describes the product as "bard port" mri dual implanted port instead of a "bard port mri implanted port" as correctly indicated on the main label of the kit.
  • Action
    A "Labeling Discrepancy Notification" letter was sent to US consignees via FED EX on February 16, 2012 and on February 20, 2012 for the foreign consignee explaining the labeling discrepancy and providing a visual example of the incorrect label. The customers were given the option of continuing to use the product with the understanding the end flap label was incorrect or they could return the affected products for replacement (Call 1-800-290-1689 to arrange a replacement).

Device

Device Recall BardPort M.R.I. Implanted Port
  • Model / Serial
    Product Number: 0607173  Lot Numbers: RESF0856, RESH0067, RESH1150.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- USA, including the states of CA, CT, FL, KS, IL, MI, MN, OH, OK, SD, TN, TX, VA, WA and the country of Belgium.
  • Product Description
    BardPort M.R.I. Implanted Port with Attachable 6 Fr. ChronoFlex Open-Ended Single-Lumen Venous Catheter and Peel-Apart Introducer Kit. Subcutaneous implanted intravascular infusion port and catheter is used to provide repeated access to the vascular system for the delivery of medications, intravenous fluids, parenteral nutrition solutions, and blood products. They are also indicated for the withdrawal of blood samples.
  • Manufacturer
    Bard Access Systems

Manufacturer

Bard Access Systems
  • Manufacturer Address
    Bard Access Systems, 605 North 5600 West, Salt Lake City UT 84116-3738
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA