Reported Feb 24, 2016 · Terminated
Best Practice Kits containing certain production lots of Endo GIA Ultra Universal Stapler Handles Product Usage: The…
Medtronic
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic · 60 Middletown Ave · North Haven, CT · 06473-3908
Is this the product you have?
- Best Practice Kits containing certain production lots of Endo GIA Ultra
- Universal Stapler Handles Product UsageThe 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
- Lot codes and dates
- Kit Lot numbersENDOBARIATRICR ENDOBARIATRICS ENDOTHORACICL ENDOTHORACICS ENDOTHORACICW THORACICRR1 00Z2363 00Z2364 00Z2387
115 of 115 codes
00B020300Z192400Z199200Z199300Z203000Z206200Z206300Z207200Z208100Z209000Z209800Z211700Z211900Z212100Z212200Z212300Z212400Z212900Z213000Z213300Z213800Z213900Z214300Z214500Z214600Z214700Z214800Z215000Z215100Z215200Z215300Z215400Z215500Z215900Z216000Z216100Z216300Z216400Z216600Z216700Z217100Z217200Z217400Z217500Z217600Z217700Z217900Z218100Z218200Z218300Z218400Z218700Z219000Z219100Z219200Z219300Z219400Z219800Z219900Z2200
- Kit Lot numbers
- Amount recalled
- 2711 kits
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
- GA
Why it was recalled
Staplers fail to fire or partially fire and reports of the instrument articulating lever disengaging during use
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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