Device 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 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.
Z-1730-2024
Product summary
- Event
- Event 94256
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 649 devices
- Official record key
device-enforcement:Z-1730-2024
Official wording
Reason: Potential of the nozzle separating during patient use.
Code information: UDI/DI 14250892903603, All lots prior to June 2023 or with a serial number before 04I00122 are potentially affected.
Distribution pattern: US nationwide distribution.
Derived failure modes
-
Unknown
Potential of the nozzle separating during patient use.