medical Class II Updated 2018-07-25

COVIDIEN MEDTRONIC recalls Endo GIA 45 mm Articulating Medium/Thick Reload with Tri-Sta

Recalled Product

Endo GIA 45 mm Articulating Medium/Thick Reload with Tri-Staple Technology, Item Code EGIA45AMT


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: N7L0521KX, N7M0047KX, N7M0592KX, N7M1001KX, N7L0975KX, N7M0434KX, N7M0683KX, N8A0203KX, N7L1057KX, N7M0528KX, N7M0937KX, N8A0677KX, N7L1098KX, N7M0529KX, N7M0949KX, N8C0144KX & N7L1099KX
View official government recall

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