Covidien, LP: Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX LOBECTOMIA VATS 3D; CFN: BOX06170V4;

Hazard

A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion.

Details from the source

Reason for recall: A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion. Distribution: Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Chile, Estonia, Finland, France, Germany, Greece, Hungary, Israel, Italy, Japan, Kuwait, Malaysia, Netherlands, Poland, Portugal, Romania, Saudi Arabia, Slovakia, Spain, United Kingdom. Quantity: 2 units (OUS only) Lot/code info: CFN: BOX06170V4; UDI-DI: 00763000988975; Lot numbers: 0231961695;

UPC codes

00763000988975

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.