United StatesCovidien Signia Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin), CFN SIGSDL45CTVT (UDI-DIs 20884521741840, 10884521741843; lot N5F1971Y, N5F1723Y, N5D1858UY, N5B1134UY), and the same reload packaged as BOX LOBECTOMIA VATS 3D, CFN BOX06170V4 (UDI-DI 00763000988975; lot 0231961695), are affected. A manufacturing issue can produce a malformed cover tube press that may allow internal components to move during firing, potentially causing uncontrolled motion.
What's being recalled
Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT;
Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX LOBECTOMIA VATS 3D; CFN: BOX06170V4;
Recalling firm: Covidien, LP, North Haven, CT, United States.
How to identify it
CFN: SIGSDL45CTVT; UDI-DIs: (1) 20884521741840, (2) 10884521741843; Lot numbers: N5F1971Y, N5F1723Y, N5D1858UY, N5B1134UY; CFN: BOX06170V4; UDI-DI: 00763000988975; Lot numbers: 0231961695;
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)