FDA Device Recall Z-1730-2024

Vyaire Medical, Inc. · Hochberg, N/A

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.

Device

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 / serial / GTIN: UDI/DI 14250892903603, All lots prior to June 2023 or with a serial number before 04I00122 are potentially affected.

Quantity: 649 devices

Reason for recall

Potential of the nozzle separating during patient use.

Recall record

Recall number: Z-1730-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: US nationwide distribution.
Recall initiated: 2024-04-08
Classified by FDA Center: 2024-05-08
FDA published: 2024-05-15
Recalling firm: Vyaire Medical, Inc.
Firm location: Hochberg, N/A, Germany

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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