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Open, Classified

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.

FDA Recall Z-1730-2024 · Posted 2024-05-08

Recalling FirmVyaire Medical, Inc.
Recall StatusOpen, Classified
Product CodeBZC
Date Initiated2024-04-08
Product Quantity649 devices

Reason for Recall

Potential of the nozzle separating during patient use.

Firm 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].

Root Cause

Process control

Distribution Pattern

US nationwide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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