Events

Recall of Device Recall FloTrac Sensor

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

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
    65984
  • Event Risk Class
    Class 2
  • Event Number
    Z-2189-2013
  • Event Initiated Date
    2013-07-31
  • Event Date Posted
    2013-09-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121142
  • 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
    Transducer, blood-pressure, extravascular - Product Code DRS
  • Reason
    The edwards lifesciences flotrac sensor is being recalled due to a manufacturing non-conformance related to incorrect packaging configuration where the ifu was placed on top of the tyvek instead of being placed at the bottom of the box. there is no evidence available at this time that could validate the sterility of this incorrect packaging configuration.
  • Action
    Edwards Lifesciences initiated a US recall via an Urgent Product Recall letter dated July 31, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised that an Edweards Lifesciences representative would come to their facility to retrieve the affected device. A device replacement would be provided to the customer. Customers were asked to complete the enclosed Confirmation Form and give it to the Edwards Lifesciences representative that will come to their facility. For customers with questions were instruct4ed to call Edwards Customers Service at 1-800-424-3278. For questions regarding this recall call 972-410-7100.

Device

Device Recall FloTrac Sensor
  • Model / Serial
    595531157
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including MO and MI.
  • Product Description
    "***Flo Trac Sensor Model MHD85***" || Sterile, single use kit that monitors pressures when attached to pressure monitoring catheters.
  • Manufacturer
    Edwards Lifesciences, LLC

Manufacturer

Edwards Lifesciences, LLC