Vyaire Twin Tube Sample Line Nozzle Separation Recall
Vyaire Medical recalls Twin Tube sample line 240 cm devices (Model V-707327) due to potential nozzle separation during patient use. All lots manufactured prior to June 2023 are potentially affected.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, which carries a minimum severity score of 4. Although no reported injuries or deaths are mentioned in the source, the Class I classification reflects significant potential for serious adverse health consequences.
Plain-English summary
Vyaire Medical, Inc. is recalling the Twin Tube sample line 240 cm (Model Number V-707327), a component of the Vyntus CPX breath analysis system used in metabolic response studies. Approximately 649 devices have been distributed nationwide in the United States.
The nozzle of the sample line has the potential to separate during patient use. This defect triggered the FDA Class I recall designation.
The recall affects all lots manufactured prior to June 2023 or bearing serial numbers before 04I00122.
The recalled product
- 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.…
- Manufacturer
- Vyaire Medical, Inc.
- Hazard
- Affected units
- 649
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI/DI 14250892903603
Distribution
Distributed nationwide across the United States.
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