Events

Recall of Device Recall Edwards Lifesciences Ergonic Double Acting DeBakey Forceps with Narrow Straight Tip

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
    66934
  • Event Risk Class
    Class 3
  • Event Number
    Z-0560-2014
  • Event Initiated Date
    2013-11-20
  • Event Date Posted
    2013-12-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-02-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124249
  • 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
    Forceps - Product Code HTD
  • Reason
    Edwards lifesciences is recalling one lot of ergonic instrument due to mislabeling. ergonic scissors standard curved labeled as a double acting debakey forcep. edwards control confirmed that the laser etching on the device was incorrect.
  • Action
    Edwards sent an " Urgent Field Safety Notice" to all affected customers dated November 20, 2013. The letter identified the product the problem and the action needed to be taken by the customers. Action to be taken by user: Our records show that you received one of these instruments. Our sales representative will be on-site to remove this instrument and provide a replacement. Please assist our sales representative in reviewing your entire inventory for the instrument listed in the recall letter. The form has been pre-populated with the inventory from our records. If you have additional inventory of this affected lot within your control, please add the quantity to the section on the form provided. Please remove the instrument from use, quarantine the device at your site and support the Edwards Sales Representative to return this product to Edwards. An acknowledgment form is included to assist you in the assessment of your inventory. While our sales representative is on-site, please complete the attached acknowledgment form and fax it back to Edwards Customer Service at 800.422.9329. The return of this form allows us to confirm that you have reviewed this notice and have taken appropriate action. Please contact Customer Service at 800.424.3278 if you have questions about the return and crediting process. The Customer Service organization can answer questions about tracking of the replacement instrument provided by the Edwards Sales Representative. If you have questions that have not been answered by this letter, please call Edwards Customer Service at 800.424.3278 from the hours of 6:00AM - 4:30PM PST .

Device

Device Recall Edwards Lifesciences Ergonic Double Acting DeBakey Forceps with Narrow Straight Tip
  • Model / Serial
    Lot Number: 11211566.1, Exp. Date: 09/01/2017.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed to 3 customers in FL only.
  • Product Description
    Edwards Lifesciences Ergonic Double Acting DeBakey Forceps with Narrow Straight Tip. Model Number ERGF01330. || The Edwards Surgical Instruments are designed to perform specialized functions in specific cardiac surgical or endoscopic procedures.
  • Manufacturer
    Edwards Lifesciences, LLC

Manufacturer

Edwards Lifesciences, LLC
  • Manufacturer Address
    Edwards Lifesciences, LLC, 12050 Lone Peak Pkwy, Draper UT 84020-9414
  • Manufacturer Parent Company (2017)
    Edwards Lifesciences Corporation
  • Source
    USFDA