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.
Recall
- Recall Number
- Z-1730-2024
- Event Number
- 94256
- Firm
- Vyaire Medical, Inc. Leibnizstr. 7 Hochberg Germany
- FEI Number
- 1000271197
- Product Code
- BZC
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- April 8, 2024
- Posted
- May 8, 2024
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.
Potential of the nozzle separating during patient use.
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- [email protected].
US nationwide distribution.
649 devices