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.
This recall is currently active, issued May 8, 2024. It was issued by Vyaire Medical, Inc. Leibnizstr. 7 Hochberg Germany.
- Recall Initiated
- April 8, 2024
- Posted
- May 8, 2024
- Recall Number
- Z-1730-2024
- Quantity
- 649 devices
- Official Source
- View on FDA website ↗
Reason for Recall
Potential of the nozzle separating during patient use.
Distribution
US nationwide distribution.
Lot / Code Info
UDI/DI 14250892903603, All lots prior to June 2023 or with a serial number before 04I00122 are potentially affected.
Root Cause
Process control
Action Taken
Vyaire Medical issued an URGENT Field Safety Notice to its consignees on 04/08/2024 via email. The notice explained the issue, requested a pull out test for all affected devices to verify the adhesive is adequate prior to use. If the product was further distributed, the party distributing device was directed to notify those to whom the device was sent. For any additional questions or concerns, please contact Vyaire at GMBEMEA- FSCA-RDX-INTL@Vyaire.com.