PlainRecalls
FDA Devices Critical Class I Ongoing

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.

Reported: May 15, 2024 Initiated: April 8, 2024 #Z-1730-2024

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.

Details

Recalling Firm
Vyaire Medical, Inc.
Units Affected
649 devices
Distribution
US nationwide distribution.
Location
Hochberg, N/A

Frequently Asked Questions

What product was recalled?
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.. Recalled by Vyaire Medical, Inc.. Units affected: 649 devices.
Why was this product recalled?
Potential of the nozzle separating during patient use.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 15, 2024. Severity: Critical. Recall number: Z-1730-2024.