Endo GIA" Auto Suture" Universal Articulating Loading Unit 45mm - 2.5mm( Item Code 030454) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The s
Check against the official notice below — it lists the full affected range.
Covidien Medtronic is recalling Endo GIA Auto Suture Universal Articulating Loading Units (45mm - 2.5mm, Item Code 030454) because some units may be missing a sled component, which is responsible for deploying staples during surgical use. The missing component could result in failure to form a staple line when tissue is divided, potentially leading to bleeding or leakage of internal contents. A total of 171,271 units have been distributed worldwide and throughout the United States across 18 affected lot numbers.
The recall affects specific lot numbers including N7K1146KX, N7L0355KX, N7L1119KX, N7M0088KX, and others through N8C0630KX. The source document does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Worldwide and US Nationwide Quantity: 171,271 units in total Lot/code info: Lots: N7K1146KX, N7L0355KX, N7L1119KX, N7M0088KX, N7M0343KX, N7M0477KRX, N7M0509KX, N7M0520KX, N7M0521KX, N8A0312KRX, N8A0360KX, N8A0433KX, N8A0434KX, N8A0435KX, N8B0487KX, N8C0026KX, N8C0119KX, N8C0630KX GTIN # 1 (Inner Carton) - 10884523002850 GTIN # 2 (Outer Carton)- 20884523002857
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.