Vyaire Medical, Inc.: Vyaire Twin Tube Sample Lines Recalled for Nozzle Separation Risk

Agency Publication Date: May 8, 2024

Summary

Vyaire Medical is recalling approximately 649 units of the Vyaire Twin Tube sample line (240 cm) due to a defect where the nozzle may separate from the tube during use. This specific component, model number V-707327, is used with the Vyntus CPX system for metabolic response studies and breath analysis. The recall affects all lots manufactured prior to June 2023 or those with a serial number before 04I00122. If you are using this device, you should contact Vyaire Medical or your healthcare provider for instructions on how to handle affected units.

Risk

The nozzle on the Twin Tube sample line can detach or separate during patient use, which could disrupt the breath analysis or metabolic response study and potentially interfere with patient monitoring.

What You Should Do

Identify your product by checking for the Vyaire Twin Tube sample line (240 cm), Model Number V-707327, and UDI/DI 14250892903603.
Check the manufacturing date and serial number on the packaging; affected units include all lots produced before June 2023 or any device with a serial number before 04I00122.
If you identify an affected sample line, contact Vyaire Medical, Inc. or your healthcare provider immediately for further instructions and information on a potential refund or replacement.
For additional information, you can contact Vyaire Medical's distributor at Leibnizstr. 7, Hochberg, Germany.
For further questions regarding this recall, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer contact for instructions.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm

Model / REF:

V-707327

Lot Numbers:

Serial numbers before 04I00122

Date Ranges: All lots prior to June 2023

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94256

Status: Active

Manufacturer: Vyaire Medical, Inc.

Sold By: Vyaire Medical, Inc.

Manufactured In: Germany

Units Affected: 649 devices

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify your product by checking for the Vyaire Twin Tube sample line (240 cm), Model Number V-707327, and UDI/DI 14250892903603.

Check the manufacturing date and serial number on the packaging; affected units include all lots produced before June 2023 or any device with a serial number before 04I00122.

If you identify an affected sample line, contact Vyaire Medical, Inc. or your healthcare provider immediately for further instructions and information on a potential refund or replacement.

For additional information, you can contact Vyaire Medical's distributor at Leibnizstr. 7, Hochberg, Germany.

For further questions regarding this recall, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.