—#124249

Product

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.

FDA product code: HTD — Forceps
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot Number: 11211566.1, Exp. Date: 09/01/2017.

Why it was recalled

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.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

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 .

Recalling firm

Firm: Edwards Lifesciences, LLC
Address: 12050 Lone Peak Pkwy, Draper, Utah 84020-9414

Distribution

Distribution pattern: Distributed to 3 customers in FL only.

Timeline

Recall initiated: 2013-11-20
Posted by FDA: 2013-12-21
Terminated: 2014-02-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #124249. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.