Avanta administration tube sets may not engage the flow control valve

Plain-English summary

Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT, Part 2 of 2), used with the Medrad Avanta Injection System, covering material numbers 87629007, 60729458 and 86566648, are being recalled. The action covers 11,300 units, 1,650 in the United States and 9,650 elsewhere.

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, and where engagement is achieved through applied force the connection is unstable. The FDA classified the action as Class II.

Distribution was worldwide, including nationwide in the United States across a large number of states. The tube sets are supplied to healthcare facilities rather than sold to consumers.

Facilities should identify affected stock using the catalog and material numbers in the recall notice, quarantine it, and follow the instructions issued by the manufacturer.

The recalled product

Product

Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with the Medrad¿ Avanta Injection System; Catalog number: AVA 500 MPAT (Part 2 of 2); Affected material numbers: 87629007, 60729458, 86566648;

Manufacturer

Bayer Medical Care, Inc.

Category

Medical Device — Contrast injection tube set

Hazard

• fit-issue
• unstable-connection
• contrast-injection
• class-ii

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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