Events

Recall of Device Recall Edwards Lifesciences VANTEX Central Venous Catheter Set

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
    36817
  • Event Risk Class
    Class 2
  • Event Number
    Z-0318-2007
  • Event Initiated Date
    2006-11-02
  • Event Date Posted
    2006-12-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49401
  • 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 Set Venous - Product Code FOZ
  • Reason
    Lack of assurance of sterility-device packaging was manufactured with an incorrect lid that could compromise the sterility of the product.
  • Action
    Edwards initiated the recall in the US by sending a voicemail on November 2, 2006, to their sale representative requesting of all unused product from one domestic customer. The Sale representative was provided with a recall letter for the cutomer to facilitate notification. Edwards requested that either the customer or the Sale Representative provide written verification of stock and identify any unused product to be returned . This will allow Edwards to track the effectiveness of this recall. Their Eurpoe operations initiated a similar recall plan in Europe on November 2, 2006.

Device

Device Recall Edwards Lifesciences VANTEX Central Venous Catheter Set

Manufacturer

Edwards Lifesciences Corporation of Puerto Rico
  • Manufacturer Address
    Edwards Lifesciences Corporation of Puerto Rico, Hwy # 402 North, Km 1.4, International Industrial Park, Anasco PR 00610-1576
  • Source
    USFDA