FDAFDA · Food and drugs·Recall number Z-1730-2024
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.
Published May 15, 2024 · Recall initiated: April 8, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential of the nozzle separating during patient use.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Vyaire Medical, Inc.
- Distributor
- US nationwide distribution.
- Lot
- UDI/DI 14250892903603, All lots prior to June 2023 or with a serial number before 04I00122 are potentially affected.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- Germany
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