Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm- 2.0mm ( Item Code 030450) 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 the Endo GIA Universal Articulating Loading Unit 30mm-2.0mm (Item Code 030450) due to a manufacturing defect. Approximately 171,271 units worldwide may be missing a sled component, which is the part responsible for deploying staples during surgical procedures. Without this component, the device may fail to form a proper staple line when tissue is divided, potentially causing bleeding or leakage of internal contents.
The affected product was distributed worldwide and throughout the United States. The recall involves five specific lot codes: N7L0306KX, N7M0221KX, N8B0724KX, N8C0958KX, and N8C1303KRX. The source document does not specify what actions affected consumers should take in response to this recall.
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: N7L0306KX, N7M0221KX, N8B0724KX, N8C0958KX, N8C1303KRX GTIN # 1 (Inner Carton) -GTIN #1 10884523002812 GTIN # 2 (Outer Carton)- GTIN # 2 20884523002819
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.