Z-1730-2024Class I

Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-707327; The TwinTube sample line...

Name: Z-1730-2024 Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-707327; The TwinTube sample line...
Creator: Vyaire Medical, Inc.
Published: 2024-04-08
License: https://open.fda.gov/license/

Jaeger Medical GmbH / initiated 2024-04-08 / Open, Classified / root cause: manufacturing process

FDA source

Vyaire Medical, Inc. began a recall of 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... on 2024-04-08. FDA classified it as Class I and gives the reason as "Potential of the nozzle separating during patient use". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1730-2024
Classification: Class I
Status: Open, Classified
Initiated: 2024-04-08
Posted: 2024-05-08
Recalling firm: Jaeger Medical GmbH
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.
Product code: BZC Calculator, Pulmonary Function Data
Reason for recall: Potential of the nozzle separating during patient use.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Vyaire Medical issued an URGENT Field Safety Notice to its consignees on 04/08/2024 via email. The notice explained the issue, requested a pull out test for all affected devices to verify the adhesive is adequate prior to use. If the product was further distributed, the party distributing device was directed to notify those to whom the device was sent. For any additional questions or concerns, please contact Vyaire at GMBEMEA- [email protected].
Quantity in commerce: 649 devices
Distribution: US nationwide distribution.
Product codes and lots: UDI/DI 14250892903603, All lots prior to June 2023 or with a serial number before 04I00122 are potentially affected.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1730-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1730-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-05-15	2024-05-08

Product code BZC

K150810Class IIVyntus / SentrySuite Product LineCarefusion Germany 234 GmbH / cleared 2015-08-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)