Reported Jun 10, 2026 · Ongoing
Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with the Medrad¿ Avanta Injection…
Bayer Medical Care, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bayer Medical Care, Inc. · 1 Bayer Dr · Indianola, PA · 15051-9702
Is this the product you have?
3 of 3 products
| # | Product as published |
|---|---|
| 1 | Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with the Medrad¿ Avanta Injection System |
| 2 | Catalog number: AVA 500 MPAT (Part 2 of 2) |
| 3 | Affected material numbers: 87629007, 60729458, 86566648 |
- Lot codes and dates
- Catalog numberAVA 500 MPAT (Part 2
- of 2) Affected material numbers
876290076072945886566648
- Affected batch numbers
251702252302252502252602252702252802253304253702253704253804254202254304254704254802
- Amount recalled
- 11,300 units (1650 US, 9650 OUS)
Where it was sold
Why it was recalled
Supplier changes resulted in a fit issue with the Contrast Flow Control Valve (CFCV) interface on the Avanta Injector System. Multiple customer reports indicate that the stopcock cannot be reliably engaged with the 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.
This product could cause temporary or reversible health problems — stop using it.
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