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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 Recall
LigaSure Blunt Tip Laparoscopic Sealer/Divider
see related information
Date Posted January 25, 2011
Recall Status1 Terminated on March 27, 2012
Recall Number Z-0954-2011
Recall Event ID 57498
Premarket Notification
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, Colorado 80301-3202
Consumer Instructions Contact the recalling firm for information
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.
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 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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