Health product recall

Avanta Fluid Injection System - Multi-Patient Sterile Disposable Sets

Last updated

Summary

Product
Avanta Fluid Injection System - Multi-Patient Sterile Disposable Sets
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

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
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies
Bayer Medical Care Inc. Also Doing Business As Medrad, Inc.
1 Bayer Drive, Indianola, Pennsylvania, United States, 15051
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-82073

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