Reported May 15, 2024 · Ongoing
Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-707327; The TwinTube sample line 240cm is used…
Vyaire Medical, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Vyaire Medical, Inc. · Leibnizstr. 7 · Hochberg, N/A · N/A
Is this the product you have?
- 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.
- Lot codes and dates
- UDI/DI 14250892903603, All lots prior to June 2023 or with a serial number before 04I00122 are potentially affected.
- Amount recalled
- 649 devices
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Potential of the nozzle separating during patient use.
Using this product could cause serious injury, illness or death — stop using it now.
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