Reported Feb 24, 2016 · Terminated
Covidien Endo GIA Ultra Universal 12 mm XL Stapler Handle Ref: EGIAUXL Product Usage: The Endo GIA Ultra Universal…
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?
- Covidien Endo GIA Ultra
- Universal 12 mm XL Stapler Handle RefEGIAUXL
- 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
- Lot
- numbers within each range are affected
Lot # starting with P3C through P5B0454XP5B0468XP5C0152X through P5E0450X
- Individual Lot Number
P5B0468XP5E0523XP5E0273X
- Amount recalled
- 327,797 units
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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