Events

Recall of Device Recall MRI Low Profile Single Lumen port with OpenEnded 6.6Fr Silicone Catheter.

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
    66991
  • Event Risk Class
    Class 2
  • Event Number
    Z-0814-2014
  • Event Initiated Date
    2013-12-06
  • Event Date Posted
    2014-01-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-08-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124441
  • 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
    Catheter,intravascular,therapeutic,short-term less than 30 days - Product Code FOZ
  • Reason
    Bard access systems is recalling various low profile port with 6.6 fr single lumen broviac catheter because a small number of silicone catheters in the may be undersized to 5.3 fr instead of 6.6 fr as stated in the labeling for the device.
  • Action
    BARD sent an Urgent Product Recall letter dated October 2013 to affected customers via certified letter. The letter identified the affected product, problem and actions to be taken. Customers were asked to check all inventory locations, remove and return any unused affected prodcut to Bard Access Systems through return goods authorization number RAP80498 for a credit or replacement, and to complete the Reply Form and Inventory Reconcilation Form. For questions contact BAS Customer Service at 1-800-290-1689.

Device

Device Recall MRI Low Profile Single Lumen port with OpenEnded 6.6Fr Silicone Catheter.
  • Model / Serial
    Lot REXC0931 and REXC0736
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US nationwide, Belgium, and Canada.
  • Product Description
    MRI Low Profile Single Lumen port with Open-Ended 6.6Fr Silicone Catheter. Product Code 0603880. || Product Usage: || The 6.6 Fr Open-Ended Single-Lumen venous catheters is packaged into various Bard Acess Systems finished goods as Attachable or Preconnected catheters in BardPort Implanted Port Kits These products are used for patient therapies requiring repeated access to the vascular system. They are indicated for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. Subject ports are not indicated to Power Injection. Port access is performed by percutaneous needle insertion using a non-coring needle. The system consists of two primary components: an injection port with a self-sealing silicone septum and a radiopaque silicone catheter.
  • 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