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U.S. Department of Health and Human Services

Class 3 Device Recall Edwards Lifesciences Ergonic Double Acting DeBakey Forceps with Narrow Straight Tip

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  Class 3 Device Recall Edwards Lifesciences Ergonic Double Acting DeBakey Forceps with Narrow Straight Tip see related information
Date Initiated by Firm November 20, 2013
Date Posted December 21, 2013
Recall Status1 Terminated 3 on February 10, 2014
Recall Number Z-0560-2014
Recall Event ID 66934
Product Classification Forceps - Product Code HTD
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.
Code Information Lot Number: 11211566.1, Exp. Date: 09/01/2017.
Recalling Firm/
Manufacturer		 Edwards Lifesciences, LLC
12050 Lone Peak Pkwy
Draper UT 84020-9414
For Additional Information Contact Suzanne Carpenter
801-565-6195
Manufacturer 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.
FDA Determined
Cause 2		 Labeling mix-ups
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 .
Quantity in Commerce 3
Distribution Distributed to 3 customers in FL only.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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