United StatesThe COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula (REF 6FEN, UDI‑DI 60884522007028, Lot 25H0868JZX) — a double‑cannula tracheostomy tube with reusable inner cannula and a radiopaque PVC outer cannula — is being recalled. The recall was initiated after a customer complaint of incorrect display box labeling; 1,002 units were distributed worldwide, including nationwide in Texas and to France, French Polynesia, Italy, Pakistan, Poland, Portugal, Spain, and Taiwan.
What's being recalled
COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are intended for use in providing tracheal access for airway management. Shiley Tracheostomy Tubes are double cannula tracheostomy tubes with reusable inner cannulae (LPC, FEN, CFS, CFN, LGT) and twist-lock connectors. These Shiley Tracheostomy Tubes have a radiopaque, biocompatible outer cannula constructed of polyvinyl chloride.
Recalling firm: Covidien LLC, Boulder, CO, United States.
How to identify it
Product Number: 6FEN UDI-DI code: 60884522007028 Lot Number: 25H0868JZX
The hazard
Due to customer complaint regarding incorrect display box labeling.
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 - U.S.: Nationwide distribution in the state of TX and the countries of France, French, Polynesia, Italy, Pakistan, Poland, Portugal, Spain, and Taiwan.
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)
Canada