FDA Medical Device Recalls (openFDA)
Vyaire Medical, Inc.: 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.
- Recall number
- Z-1730-2024
- Recalling firm
- Vyaire Medical, Inc.
- 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.
- Status
- Open, Classified
- Initiated
- 2024-04-08
- Posted
- 2024-05-08
- Terminated
- not on file
- Reason
- Potential of the nozzle separating during patient use.
- 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- FSCA-RDX-INTL@Vyaire.com.
- Quantity
- 649 devices
- Distribution
- US nationwide distribution.
- Lot, serial or model codes
- UDI/DI 14250892903603, All lots prior to June 2023 or with a serial number before 04I00122 are potentially affected.
- 510(k) numbers
- ["K150810"]
- PMA numbers
- not on file
- Product code
- BZC
- Firm FEI
- 1000271197
- Firm city
- Hochberg
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28