FDA Enforcement
Class II
Ongoing
Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm, Item Code 030450 - 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-0001-2021
·
Reported October 7, 2020
Enforcement
- Recall Number
- Z-0001-2021
- 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 Gray Universal Articulating Loading Unit 30 mm - 2.0 mm, Item Code 030450 - 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: T0A108X T7H003X T8D008X T8K108X T9G060X T0E051X T7L023X T8H047X T8M079X T7G003X T8D007X T8K047X T9F132X
Distribution
Worldwide distribution - US Nationwide and Global Distribution.
Quantity
900,007 total