Avanta Fluid Injection System - Multi-Patient Sterile Disposable Sets
Summary
Contact the manufacturer if you require additional information.
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Avanta Fluid Injection System - Multi-Patient Sterile Disposable Sets | 253304 | AVA 500 MPAT |
| Avanta Fluid Injection System - Multi-Patient Sterile Disposable Sets | 252602 | AVA 500 MPAT |
Issue
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.
Additional information
Details
| Bayer Medical Care Inc. Also Doing Business As Medrad, Inc. |
| 1 Bayer Drive, Indianola, Pennsylvania, United States, 15051 |
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