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U.S. Department of Health and Human Services

Class 2 Device Recall Covidien

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  Class 2 Device Recall Covidien see related information
Date Initiated by Firm December 02, 2015
Date Posted February 18, 2016
Recall Status1 Open3, Classified
Recall Number Z-0820-2016
Recall Event ID 72749
510(K)Number K111825  
Product Classification Staple, implantable - Product Code GDW
Product Covidien Endo GIA Ultra Universal Standard Stapler Handle
Ref: EGIAUSTND

Product Usage:
The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures. The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers when used with the Endo GIA curved tip single use reloads can be used to blunt dissect or separate target tissue from other tissue.


Code Information RANGES OF LOT NUMBERS, (all lot numbers within each range are affected), Lot # starting with P3C through P5B0521X P5D0410X through P5D0411X P5D0823X through P5D0829X , P5E0080X through P5E0082X , P5E0317X through P5E0320X , P5E0322X through P5E0324X , P5F0001X through P5F0002X

INDIVIDUAL LOT NUMBERS, (in addition to ranges), P5C0239X, P5C0241X, P5C0508X, P5C0510X, P5C0512X, P5C0597X P5C0599X, P5C0601X, P5C0603X, P5C0684X, P5C0803X, P5C0805X, P5C0807X. P5E0527X, P5E0529X

, P5D0067X, P5D0069X , P5D0073X, P5D0170X, P5D0413X, P5D0415X ,P5D0417X, P5D0419X, P5D0447X, P5D0623X, P5D0624X ,P5D0626X, P5D0628X

P5D0630X, P5E0525X, P5F0004X, P5F0006X, P5F0008X, P5F0010X, P5F0014X, P5F0017X, P5F0019X, P5F0021X, P5F0213X, P5F0217X



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Recalling Firm/
Manufacturer
Medtronic
60 Middletown Ave
North Haven CT 06473-3908
Manufacturer Reason
for Recall
Staplers fail to fire or partially fire and reports of the instrument articulating lever disengaging during use
FDA Determined
Cause 2
Process control
Action Medtronic sent an Urgent Medical Device Recall letters dated December 2 2015 and an Updated Urgent Medical Device Recall letter dated January 13, 2016, to affected customers, via Federal Express. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue use of the product and return all inventory to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473. For questions or concerns, please do not hesitate to contact your Medtronic representative or Customer Service at (800) 882-5878.
Quantity in Commerce 1,102,166 units
Distribution Worldwide Distribution - US Nationwide and the countries of Canada, Albania, ALGERIA, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Gabon, Georgia, Germany, Greece, Greece, Guatemala, Honduras, Hungary, Iceland, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Mauritius, Mexico, Monaco, Montenegro, Morocco, Namibia, Netherlands, Nicaragua, Nigeria, Norway, Panama, Paraguay, Peru, Poland, Portugal, Romania, Russia, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, UAE, Ukraine, United Kingdom, Uruguay, Venezuela, and Zimbabwe.
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, FORMERLY US SURGICAL A DIVISON OF TYCO H
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