Ethicon Endo-Surgery Inc: ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear Cutter Reload (+Gripping Surface technology), 45MM WHITE VAS

Hazard

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.

Details from the source

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: Worldwide distribution - US Nationwide and the countries of Canada and Brazil. Quantity: 22,616 (US), 4,476 (OUS) Lot/code info: UDI-DI 10705036014928 Lots 442C02 and 442C03

UPC codes

10705036014928

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.