FDAFDA · Food and drugs·Recall number Z-1891-2024
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
Published June 5, 2024 · Recall initiated: April 15, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may cause a delay in surgery
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Covidien, LP
- Distributor
- Worldwide - US Nationwide distribution in the state of NJ and the countries of Australia, Japan, New Zealand, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand.
- Lot
- GTIN: 10884521717633 20884521717630 Lot #: N3G1372Y
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.