FDA Enforcement
Class II
Ongoing
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.
Recall: Z-0004-2021
·
Reported October 7, 2020
Enforcement
- Recall Number
- Z-0004-2021
- Event ID
- 86214
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Covidien, LP
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 7, 2020
- Initiation Date
- August 12, 2020
- Classification Date
- October 1, 2020
- Address
- 60 Middletown Ave, N/A, North Haven, CT, 06473-3908, United States
Description
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.
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 Info
Lot Numbers: T7F017X T7J023X T7L032X T7L034X T8L100X T7F025X T7J024X T7L033X T7L035X T9F138X T7F026X T7K020X
Distribution
Worldwide distribution - US Nationwide and Global Distribution.
Quantity
900,007 total