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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Medtronic
- Reason for Recall:
- Staplers fail to fire or partially fire and reports of the instrument articulating lever disengaging during use
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0819-2016
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