Z-0834-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- February 7, 2024
- Initiation Date
- December 11, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22,616 (US), 4,476 (OUS)
Product 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 for Recall
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada and Brazil.
Code Information
UDI-DI 10705036014928 Lots 442C02 and 442C03