FDA-Device2024-05-15Class I

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 TwinTube sample line 240cm is connected to the adapter for DVT. Twin Tube Probenschlauch (707004), which is sold outside the US only. Used in breath analysis for metabolic response study.

Vyaire Medical, Inc.
Hazard

Potential of the nozzle separating during patient use.

Sold states
US nationwide distribution.
Affected count
649 devices
Manufactured in
Leibnizstr. 7, N/A, Hochberg, N/A, Germany
Products
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 TwinTube sample line 240cm is connected to the adapter for DVT. Twin Tube Probenschlauch (707004), which is sold outside the US only. Used in breath analysis for metabolic response study.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1730-2024

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