Vyaire Medical, Inc. Recall 94256
Description: 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. Recall 94256 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1730-2024 |
| Event ID | 94256 |
| Event Description | 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. |
| Product Type | Devices |
| Distribution | US nationwide distribution. |
| Quantity | 649 devices |
| Recall Reason | Potential of the nozzle separating during patient use. |
| Device Classification | 20240515 |
| Device Code Info | UDI/DI 14250892903603, All lots prior to June 2023 or with a serial number before 04I00122 are potentially affected. |
| Center Classification Date | 20240508 |
| Recall Initiation Date | 20240408 |
| Recalling Firm | Vyaire Medical, Inc. |
| Initial Notification | |
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