Endo GIA" Auto Suture" Universal Articulating Loading Unit 60mm - 3.5mm ( Item Code 030458) 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
Check against the official notice below — it lists the full affected range.
Covidien Medtronic is recalling the Endo GIA Auto Suture Universal Articulating Loading Unit 60mm - 3.5mm (Item Code 030458) because the device may be missing a sled component, which is responsible for deploying staples. Without this component, the stapler may fail to form a proper staple line when tissue is divided during surgery. This could result in bleeding or leakage of luminal contents. The recall affects 171,271 units distributed worldwide and throughout the United States across 26 specific lot codes.
The product recall source does not specify a remedy 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: N7L0911KX, N7M0067KX, N7F0631KX, N7L0465KX, N7L0117KX, N7L0768KX, N7M0314KX,N7M0314KX,N7L1075KX, N7M0646KX, N7M0740KX, N7M0972KX, N8A0172KX, N8A0539KX, N8A0679KX, N8A0910KX, N8A0961KX, N8B0054KX, N8B0099KX, N8C0008KX, N8C0205KX, N8C0532KX, N8C0571KX, N8C0758KX, N8C0795KX, N8C1284KRX GTIN # 1 (Inner Carton) - 10884523002898 GTIN # 2 (Outer Carton)- 20884523002895
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.