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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 Completed
Recall Number Z-0819-2016
Recall Event ID 72749
510(K)Number K111825  
Product Classification Staple, implantable - Product Code GDW
Product Covidien Endo GIA Ultra Universal 12 mm Short Stapler Handle
Ref: EGIAUSHORT

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 P5B0289X  P5C0196X through P5C0197X  P5C0304X through P5C0307X  P5C0796X through P5C0798X  P5D0049X through P5D0051X  P5D0146X through P5D0148X  P5E0261X through P5E0262X  P5F0158X through P5F0161X  INDIVIDUAL LOT NUMBERS (in addition to ranges) N3F0260RX  N3F0266RX  N3F0267RX P5C0201X P5D0538X  P5E0680X  P5E0682X  P5E0686X P5E0760X P5E0762X  P5E0765X
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 364,768 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.
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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