Edwards Lifesciences Ergonic Double Acting DeBakey Forceps with Narrow Straight Tip. Model Number ERGF01330. The Edwards

FDA device recall Z-0560-2014 · posted 2013-12-21 · Terminated

Recall details

Recalling firm

Edwards Lifesciences, LLC

Reason for recall

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 taken

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 .

Root cause

Labeling mix-ups

Status

Terminated

Product code

HTD

Quantity affected

3

Distribution

Distributed to 3 customers in FL only.

Date initiated

2013-11-20

Date posted

2013-12-21

Date terminated

2014-02-10

Location

Draper, UT