Events

Recall of Device Recall Cuffed central venous 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
    59115
  • Event Risk Class
    Class 2
  • Event Number
    Z-2783-2011
  • Event Initiated Date
    2011-06-20
  • Event Date Posted
    2011-07-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101247
  • 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,long-term greater than 30 days - Product Code LJS
  • Reason
    Kit label indicates the wrong dimension for an enclosed introducer.
  • Action
    Bard Access Systems, Inc. notified customers by letter dated June 16, 2011. The letter notified customers of the mislabeling issue and offered a replacement product if desired. For additional information contact Bard Access Systems at 1-800-443-3393.

Device

Device Recall Cuffed central venous catheter
  • Model / Serial
    Lot Numbers: REPG0515, RERF0625, RERH0766, rerj0831, RERL0171, RESA0362, RESB0115, RESC0022, RESH0242, RESH0436, RESJ0421, RETD0946, RETE0613, RETE0676, RETF0510, RETH0051, RETH0672, RETK0471, RETK1024, REUA0207, reua0795, REUB0565, REUB0891, REUD0314, REUE891, reue1155, reuf0351, REUG0994, REUG1615, REUH1366, REUI0642, REUJ0665, REUK0190, REUL0817, REVA1056, revb0515.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution - USA (nationwide) including the states of: HI, KY, TX, VT and the country of Canada.
  • Product Description
    Bard PowerLine 6 Fr. Dual-Lumen Polyurethane Catheter with SureCuff Ingrowth Cuff, REF 0700610, Sterile, Contents...1 Each - PTFE Introducer and Dilator, 6.5 FR. x 10 cm..., Assembled in Mexico. || Product Usage: Designed for short or long term access to the central venous system. They are designed for the administration of I.V. fluids, blood products, drugs, parenteral nutrition solutions, as well as blood withdrawal and power injection of contrast media.
  • 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