medical Class II Updated 2018-07-25

COVIDIEN MEDTRONIC recalls Endo GIA 60 mm Articulating Medium/Thick Reload with Tri-Sta

Recalled Product

Endo GIA 60 mm Articulating Medium/Thick Reload with Tri-StapleTechnology, Item Code EGIA60AMT

Hazard / Issue

Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: N7L0711KX, N7L1141KX, N7M0853KX, N8B0419KX, N7L0912KX, N7M0241KX, N8A0271KX, N8C0012KX, N7L0973KX, N7M0353KX, N8A0684KX, N8C0143KX, N7L1038KX, N7M0366KX, N8A0924KX, N7M0996KX, N7L0807KX, N7M0548KX, N8A1143KX, N8A0173KX, N7L1050KX, N7M0617KX, N8B0161KX, N8A0488KX, N7L1125KX, N7M0745KX, N8B0283KX & N8C0136KX

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