CanadaAvanta Fluid Injection System multi-patient sterile disposable sets (brand Bayer Medical Care Inc./Medrad, model/catalogue AVA 500 MPAT, lots 253304 and 252602) are affected. A supplier revision to the off-the-shelf stopcock to meet ISO 80369-7 created a fit issue with the injector’s Contrast Flow Control Valve (CFCV), and the stopcock can disengage before or during contrast injection. Contact the manufacturer for additional information.
What's being recalled
Companies: Bayer Medical Care Inc. Also Doing Business As Medrad, Inc., 1 Bayer Drive, Indianola, Pennsylvania, United States, 15051.
How to identify it
Affected products: Avanta Fluid Injection System - Multi-Patient Sterile Disposable Sets; Lot or serial number: 253304; Model or catalogue number: AVA 500 MPAT
Affected products: Avanta Fluid Injection System - Multi-Patient Sterile Disposable Sets; Lot or serial number: 252602; Model or catalogue number: AVA 500 MPAT
The hazard
In April 2025, an off-the-shelf stopcock used in the Avanta Multi-Patient Administration Tube sets (AVA 500 MPAT (part 2 of 2)) was revised by the supplier to achieve ISO 80369-7 compliance and ensure connectability to other connectors. These changes resulted in a fit issue with the CFCV interface on the Avanta injector system.
Multiple customer reports indicate that the stopcock cannot be reliably engaged with the Contrast Flow Control Valve (CFCV) snap interface. In instances where engagement is achieved through applied force, the connection is unstable, and the stopcock may disengage before or during contrast injection, leading to procedure interruption.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)