Endo GIA" Auto Suture" Universal Articulating Loading Unit 45mm- 3.5mm( Item Code 030455) 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 si
Check against the official notice below — it lists the full affected range.
Covidien Medtronic is recalling 171,271 units of the Endo GIA Auto Suture Universal Articulating Loading Unit 45mm-3.5mm (Item Code 030455) distributed worldwide and throughout the US. The devices may be missing a sled component, which is responsible for deploying staples during use. If the sled component is missing, the device may fail to form a staple line when tissue is divided, potentially resulting in bleeding or leakage of luminal contents.
The recall affects specific lot numbers including N7F0576KX, N7L0032KX, N7L0239KX, N7L0519KX, N7M0104KX, N7M0383KX, N7M0584KX, N7M0696KX, N8A0036KX, N8A0324KX, N8A0477KRX, N8A0551KX, and N8C0357KX. The source record does not specify what action 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: N7F0576KX, N7L0032KX, N7L0239KX, N7L0519KX, N7M0104KX, N7M0383KX, N7M0584KX, N7M0696KX, N8A0036KX, N8A0324KX, N8A0477KRX, N8A0551KX, N8C0357KX GTIN # 1 (Inner Carton) - 10884523002867 GTIN # 2 (Outer Carton)- 20884523002864
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.