Z-1730-2024 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 15, 2024
- Initiation Date
- April 8, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 649 devices
Product 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.
Reason for Recall
Potential of the nozzle separating during patient use.
Distribution Pattern
US nationwide distribution.
Code Information
UDI/DI 14250892903603, All lots prior to June 2023 or with a serial number before 04I00122 are potentially affected.