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.
This recall has been terminated (originally issued September 15, 2017).
- Company
- Covidien Llc
- Recall Initiated
- September 15, 2017
- Terminated
- December 19, 2018
- Recall Number
- Z-0908-2018
- Quantity
- 163
- Firm Location
- North Haven, CT
- Official Source
- View on FDA website ↗
Reason for Recall
The device cartridge disengaged during use due to manufacturing error.
Distribution
Internationally, including Japan. No USA Customers
Lot / Code Info
Product number: EGIARADXT Lot code: N6L0351X
Root Cause
Process control
Action Taken
Medtronic sent an "URGENT MEDICAL RECALL LETTER" dated September 13, 2017, was issued to customers titled "Covidien Endo GIA Black Radial Reload with Tri-Staple Technology" urging customers to quarantine and return unused product to recalling firm. Questions or concerns can be directed to: feedback.customerservice@Covidien.com. For further questions, please call (203) 492-5000.
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