FDAClass IMay 15, 2024

Vyaire Medical GmbH recall

Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-707327; The TwinTube sample line 240cm is used in the Vyntus CPX. The…

Why was Vyaire Medical GmbH recalled?

Potential of the nozzle separating during patient use.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI/DI 14250892903603, All lots prior to June 2023 or with a serial number before 04I00122 are potentially affected.

Product
Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-707327; The TwinTube sample line 240cm is used in the Vyntus CPX. The…
Recalling firm
Vyaire Medical, Inc.
Quantity
649 devices
Distribution
US nationwide distribution.
Recall date
May 15, 2024
Classification
Class I
Status
Ongoing
Agency
FDA (device)
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