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U.S. Department of Health and Human Services

Class 2 Device Recall LigaSure Blunt Tip Laparoscopic Sealer/Divider

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  Class 2 Device Recall LigaSure Blunt Tip Laparoscopic Sealer/Divider see related information
Date Initiated by Firm December 08, 2010
Date Posted January 25, 2011
Recall Status1 Terminated 3 on March 27, 2012
Recall Number Z-0954-2011
Recall Event ID 57498
510(K)Number K092879  
Product Classification electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product Covidien, LigaSure, Blunt Tip Laparoscopic Sealer/Divider, 5 mm-37 cm, REF LF1537, Sterile EO, Covidien, Valleylab, a division of Tyco Healthcare Group LP, 5920 Longbow Drive, Boulder, CO 80301

Intended use: LigaSure 5 mm devices are electrosurgical instruments designed to permanently seal and divide vessels, tissue bundles, and lymphatics.
Code Information Lot No.: 188856, 190048, 190107, and 190307 through 193333 (88 lots).
Recalling Firm/
Manufacturer		 Covidien LP
5920 Longbow Dr
Boulder CO 80301-3202
For Additional Information Contact
303-581-6773
Manufacturer Reason
for Recall		 During surgical procedures, the device may energize when clamping without pushing the activation button, which could result in unintended energy delivery to tissue.
FDA Determined
Cause 2		 Device Design
Action The firm, Covidien, sent a "URGENT: PRODUCT RECALL" letter dated December 6, 2010, to the customers. The letter described the product, problem and the action to be taken by the customers. The customers were instructed to remove product from inventory, immediately quarantine the product and return any remaining stock of the lots listed to: Covidien Energy-based devices, Attention: R82, Building 4/Receiving, 5920 Longbow Drive, Boulder, CO 80301. The customers were also instructed to complete and return the Customer Response Form immediately via mail (in the envelope provided) or fax to (303) 516-8307. To return any identified product for credit or replacement, contact Customer Service at 1-800-722-8772 Option 1. Should you have any medical questions concerning this recall, please contact your local sales representative or the Covidien Clinical information Hotline at (800) 255-8522 (option 1).
Quantity in Commerce 25,009 units
Distribution Worldwide distribution: USA and countries including: Australia, Canada, France, Germany, Japan, Puerto Rico, Singapore, and Uruguay.
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.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = VALLEYLAB
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