Device product
Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Code 030453 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0004-2021
Product summary
- Firm
- Covidien, LP
- Event
- Event 86214
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 900,007 total
- Official record key
device-enforcement:Z-0004-2021
Official wording
Reason: The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.
Code information: Lot Numbers: T7F017X T7J023X T7L032X T7L034X T8L100X T7F025X T7J024X T7L033X T7L035X T9F138X T7F026X T7K020X
Distribution pattern: Worldwide distribution - US Nationwide and Global Distribution.
Derived failure modes
-
Manufacturing or process control
assembly error