FDA recall Z-1730-2024

Product

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

US nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2024-04-08

Report date

2024-05-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hochberg, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1730-2024