Recall Z-1730-2024— Vyaire Medical, Inc.
Class I · Ongoing
Class I FDA medical device recall by Vyaire Medical, Inc., initiated 2024-04-08. It names one FDA 510(k) clearance: K150810. 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: Potential of the nozzle separating during patient use..
- Recalling firm
- Vyaire Medical, Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2024-04-08
- Firm location
- Hochberg, N/A, Germany
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.