FDA Enforcement
Class II
Ongoing
Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis Model: SIGTRSB60AXT
Recall: Z-1891-2024
·
Reported June 5, 2024
Enforcement
- Recall Number
- Z-1891-2024
- Event ID
- 94484
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Covidien, LP
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 5, 2024
- Initiation Date
- April 15, 2024
- Classification Date
- May 24, 2024
- Address
- 60 Middletown Ave, North Haven, CT, 06473-3908, United States
Description
Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis Model: SIGTRSB60AXT
Reason
Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may cause a delay in surgery
Code Info
GTIN: 10884521717633 20884521717630 Lot #: N3G1372Y
Distribution
Worldwide - US Nationwide distribution in the state of NJ and the countries of Australia, Japan, New Zealand, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand.
Quantity
1681 units