FDA Enforcement
Class II
Ongoing
ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear Cutter Reload (+Gripping Surface technology), 45MM WHITE VASCULAR/THIN, Product No. GST45W
Recall: Z-0834-2024
·
Reported February 7, 2024
Enforcement
- Recall Number
- Z-0834-2024
- Event ID
- 93735
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Ethicon Endo-Surgery Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 7, 2024
- Initiation Date
- December 11, 2023
- Classification Date
- January 26, 2024
- Address
- 4545 Creek Rd, Blue Ash, OH, 45242-2803, United States
Description
ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear Cutter Reload (+Gripping Surface technology), 45MM WHITE VASCULAR/THIN, Product No. GST45W
Reason
There is the potential for incomplete staple line formation during the firing sequence, without most or all staples, which may lead to insufficient tissue apposition that could require surgical intervention. This may result in bleeding, prolonged surgery, or surgical delay.
Code Info
UDI-DI 10705036014928 Lots 442C02 and 442C03
Distribution
Worldwide distribution - US Nationwide and the countries of Canada and Brazil.
Quantity
22,616 (US), 4,476 (OUS)