FDA Enforcement
Class II
Ongoing
Covidien Best Practices Procedure Kits containing Auto Suture Endo GIA Universal Loading Units, Parent Codes 00Z2760 - 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-0009-2021
·
Reported October 7, 2020
Enforcement
- Recall Number
- Z-0009-2021
- 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
Covidien Best Practices Procedure Kits containing Auto Suture Endo GIA Universal Loading Units, Parent Codes 00Z2760 - 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: 00Z2117
Distribution
Worldwide distribution - US Nationwide and Global Distribution.
Quantity
900,007 total