United StatesThe MEDRAD Stellant FLEX Syringe Kit used with the Stellant FLEX CT Injection System (catalog number FLEXS-150-QFT; UDI‑DI 00616258022895; affected material number 87078825; affected batch number 8688750) is being recalled by Bayer Medical Care, Inc. because some devices may not have been properly sterilized due to a manufacturing sterilization issue. The recall affects 27,800 kits (556 boxes) distributed nationwide in the United States.
What's being recalled
MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT;
Recalling firm: Bayer Medical Care, Inc., Indianola, PA, United States.
How to identify it
Catalog number: FLEXS-150-QFT; UDI-DI: 00616258022895; Affected material number: 87078825; Affected batch number: 8688750;
The hazard
Some devices may not have been properly sterilized due to a manufacturing sterilization issue.
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
US Nationwide distribution.
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)