Reported Feb 24, 2016 · Terminated
Covidien Endo GIA Ultra Universal 12 mm Short Stapler Handle Ref: EGIAUSHORT Product Usage: The Endo GIA Ultra…
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 Short Stapler Handle RefEGIAUSHORT
- 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
- 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)
N3F0260RXN3F0266RXN3F0267RXP5C0201XP5D0538XP5E0680XP5E0682XP5E0686XP5E0760XP5E0762XP5E0765X
- 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)
- Amount recalled
- 364,768 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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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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