Recall Z-0908-2018— Covidien LLC
Class II · Terminated
Class II FDA medical device recall by Covidien LLC, initiated 2017-09-15, terminated 2018-12-19. It names one FDA 510(k) clearance: K132493. Product: Endo GIA" Radial Reload with Tri-Staple" Technology The Endo GIA radial reloads with Tri-Staple Technology have application in open or minimally invasive general abdominal, gynecologic and thoracic surgery for resection and transection of tissue and creation of anastomosis, as well as application deep in the pelvis, e.g. low anterior resection. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.. Reason: The device cartridge disengaged during use due to manufacturing error..
- Recalling firm
- Covidien LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-09-15
- Terminated
- 2018-12-19
- 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
Endo GIA" Radial Reload with Tri-Staple" Technology The Endo GIA radial reloads with Tri-Staple Technology have application in open or minimally invasive general abdominal, gynecologic and thoracic surgery for resection and transection of tissue and creation of anastomosis, as well as application deep in the pelvis, e.g. low anterior resection. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
Reason for recall
The device cartridge disengaged during use due to manufacturing error.
Data sourced from openFDA. This site is unofficial and independent of the FDA.