Recall Z-1891-2024— Covidien, LP
Class II · Ongoing
Class II FDA medical device recall by Covidien, LP, initiated 2024-04-15. It names one FDA 510(k) clearance: K173270. Product: 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.
- Recalling firm
- Covidien, LP
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-04-15
- Firm location
- North Haven, CT, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product 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 for recall
Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may cause a delay in surgery
Data sourced from openFDA. This site is unofficial and independent of the FDA.