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U.S. Department of Health and Human Services

Class 2 Device Recall Covidien Endo GIA

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 Class 2 Recall
Covidien Endo GIA
see related information
Date Posted April 05, 2013
Recall Status1 Terminated on March 20, 2014
Recall Number Z-1063-2013
Recall Event ID 64420
Premarket Notification
510(K) Number
K111825 
Product Classification Staple, Implantable - Product Code GDW
Product Covidien Endo GIA AutoSuture Universal Loading Unit, 30mm-2.0mm Product Code: 030450 Applications in abdominal, gynecologic, pediatric anti thoracic surgery for resection, transection and creation of anastomosis.
Code Information Lot Codes: N2F0563LX, N2F0341LX, N2F0725LX, and N2E0605LX.
Recalling Firm/
Manufacturer
Covidien LP
60 Middletown Ave
North Haven, Connecticut 06473-3908
For Additional Information Contact Same
203-492-8165
Manufacturer Reason
for Recall
Single Use Loading Unit contained two staples loaded in each cartridge pocket and may result in difficulty firing and removing the device from the application site, which may require medical intervention
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Covidien notified customers with an Urgent Medical Device Recall notification on February 11, 2013. The letter identified the affected product and the reason for the recall. Accounts were requested to quarantine and discontinue use of the affected devices, and notify Universal Loading Unit 30mm-2.0mm users of this recall. Customers should follow the instructions provided in order to return the affected product. Customers are to complete and return the Product Return Form regardless if they have any affected product or not. For questions regarding the RGA I return process, please contact Covidien Customer Service, M-F, 8 am - 6:30 pm ET at (800) 962-9888, option 1, and then option 2.
Quantity in Commerce 6,751 units
Distribution Worldwide Distribution -- USA, Asia Pacific, Canada, Europe, and Japan.
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
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GDW and Original Applicant = COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H
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