Events

Recall of Vantex Central Venous Catheter Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Edwards Lifesciences Corporation of Puerto Rico.

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
    27515
  • Event Risk Class
    Class 3
  • Event Number
    Z-0272-04
  • Event Initiated Date
    2003-10-08
  • Event Date Posted
    2003-12-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-02-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29994
  • 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
    Lot is being recalled because some of the kits contain an incorrect guidewire.
  • Action
    Customers were contacted by their Edwards Sales Representatives on 10/8/03. The Sales Representatives requested that all units be returned.

Device

Vantex Central Venous Catheter Kit

Manufacturer

Edwards Lifesciences Corporation of Puerto Rico
  • Manufacturer Address
    Edwards Lifesciences Corporation of Puerto Rico, Hwy # 402 North,Box 1576, Anasco PR 00610
  • Source
    USFDA