Ventilator Recall: React Health Removes VOCSN V+Pro Ventilators
This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Affected Product
The FDA is aware that Ventec, doing business as React Health, has issued a letter to affected customers recommending certain VOCSN V+Pro units be removed from where they are used or sold. Affected devices:
Device Name | Catalog Number | UDI-DI |
|---|---|---|
V+Pro Package | PRT-01198-000 | 00855573007914 |
V+Pro Unit | PRT-01185-000 |
What to Do
Identify and stop use of affected devices. Use a non-affected ventilator for patient support.
On March 23, React Health sent all affected customers a letter recommending the following actions:
- Immediately discontinue use of affected VOCSN V+Pro.
- Inspect current stock, quarantine/segregate any unused affected products, remove affected devices from clinical service and segregate to prevent further use.
- Use a non-affected ventilator for patient support.
- If you have distributed or transferred affected devices to other facilities, caregivers, or end users, you must promptly notify them of this recall and provide a copy of this notification.
Reason for Recall
React Health is removing affected devices due to a manufacturing process deviation that may result in an undetected oxygen leak condition.
Due to a manufacturing test configuration error, certain devices may not have been evaluated under all intended high-pressure conditions during production testing. As a result, an oxygen leak condition could occur that may lead to out of specification FiO₂ delivery prior to or during ventilation.
If an oxygen leak occurs, delivered FiO₂ may be reduced below intended levels. In oxygen-enriched environments, a leak could also increase fire risk. These conditions could potentially result in serious patient injury or death.
As of March 4, React Health has not reported any serious injuries or deaths associated with this issue.
Device Use
The VOCSN Unified Respiratory System is intended to provide continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation. It may be used in invasive and non-invasive applications. The VOCSN V+Pro device includes functions of V (ventilation) only with external high- and low-pressure oxygen capability.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact React Health at 844-698-6276.
Additional FDA Resources
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.
- How do I recognize a UDI on a label?
- AccessGUDID database - Identify Your Medical Device
- Benefits of a UDI System
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.