Events

Recall of Device Recall Hickman and Leonard Catheters

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
    64425
  • Event Risk Class
    Class 2
  • Event Number
    Z-0909-2013
  • Event Initiated Date
    2013-02-21
  • Event Date Posted
    2013-03-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116113
  • 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
    Introducer, catheter - Product Code DYB
  • Reason
    Bard access systems is recalling two lots of hickman 9.0 french and one lot of leonard 10.0 french dual lumen catheters with surecuff tissue ingrowth cuff with peel-apart percutaneous introducer systems due to the wrong size introducer being included with the kit.
  • Action
    Bard sent an Urgent Recall Notification letters dated February 2013 to all affected customers. The letter identified the affected product, problem, and actions to be taken. Customers were instructed to examine their inventory for the affected product, return any remaining in stock and complete the enclosed Reply Form and Inventory Reconciliation Form. For questions contact Bard Access Systems Customer Service at 1-800-290-1689.

Device

Device Recall Hickman and Leonard Catheters
  • Model / Serial
    Lot numbers: HUWI1379 and HUWI1380.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA Nationwide Distribution and the countries Europe, Belgium, Australia, and Latin America.
  • Product Description
    Leonard 10.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer system (product code 0600630). || Product Usage: Hickman and Leonard Catheters are designed for long-term vascular access and for use in patients that lack adequate peripheral venous access.
  • 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