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U.S. Department of Health and Human Services

Class 2 Device Recall Endo GIA Articulating Reloads with TriStaple Technology

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  Class 2 Device Recall Endo GIA Articulating Reloads with TriStaple Technology see related information
Date Initiated by Firm May 17, 2019
Create Date June 16, 2019
Recall Status1 Open3, Classified
Recall Number Z-1833-2019
Recall Event ID 82950
510(K)Number K111825  K160176  
Product Classification Staple, implantable - Product Code GDW
Product SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT
Code Information N6E0176UX N6E0278UX N6E0584UX N6E0587UX N6E0589UX N6E0590UX N6E0975UX N6F0141UX N6F0142UX N6F0143UX N6F0144UX N6F0340UX N6F0341UX N6F0342UX N6F0343UX N6F0436UX N6G0033UX N6G0034UX N6G0035UX N6G0036UX N6G0037UX N6G0038UX N6G0125UX N6G0744UX N6H0757UX N6J0436UX N6K0010UX N6K0372UX N6K0415UX N6K0990UX N6K0991UX N6K1110UX N7C0111X N7C0381X N7C0499X N7C0611X N7D0303X 
Recalling Firm/
Manufacturer		 Covidien LLC
60 Middletown Ave
North Haven CT 06473-3908
For Additional Information Contact Customer Service
800-962-9888
Manufacturer Reason
for Recall		 The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.
FDA Determined
Cause 2		 Process control
Action All consignees were notified by letter delivered via Federal Express and/or certified mail beginning May 17, 2019. The letter informs customers of the recall of specific item codes and production lots of Covidien Endo GIA Articulating Reloads with Tri-Staple Technology due to the potential for a device to be missing one of two pin components that maintain alignment of the device jaws. Through this notification customers are instructed to take the following actions: " Immediately quarantine and discontinue use of the affected item codes and lots. " Return affected product. " Forward the information to anyone who they have distributed affected Covidien Endo GIA" Articulating Reloads with Tri-Staple Technology. " Complete the Recalled Product Return Form. If you have any questions regarding this communication, please contact your Medtronic representative or Customer Service at 800-962-9888, option 2.
Quantity in Commerce 3,113,280
Distribution Nationwide domestic distribution, worldwide foreign distribution.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = GDW and Original Applicant = Covidien
510(K)s with Product Code = GDW and Original Applicant = COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H
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