A manufacturing error may lead to undetected oxygen leaks, posing risks of reduced oxygen delivery and potential fire hazards.

React Health is recalling certain VOCSN V+Pro ventilators due to a manufacturing process deviation that could result in undetected oxygen leaks. The US Food and Drug Administration has identified this as a Class I recall, the most serious type, indicating that the use of affected devices may cause serious injury or death.

The issue stems from 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 could occur, leading to out-of-specification FiO2 delivery before or during ventilation.

If an oxygen leak occurs, the 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.

Affected Products and Use

The recall affects the VOCSN V+Pro Package (Catalog Number PRT-01198-000) and the V+Pro Unit (PRT-01185-000). The VOCSN Unified Respiratory System is intended to provide continuous or intermittent ventilator support for individuals who require mechanical ventilation. It is used in both invasive and non-invasive applications. The VOCSN V+Pro device specifically includes ventilation functions with external high- and low-pressure oxygen capability.

Required Actions for Healthcare Facilities

React Health sent a letter to affected customers on March 23 recommending immediate action to mitigate patient risk. Healthcare providers and equipment managers are advised to:

  • Immediately discontinue use of affected VOCSN V+Pro units.
  • Inspect current stock and quarantine any unused affected products.
  • Remove affected devices from clinical service and segregate them to prevent further use.
  • Use a non-affected ventilator for patient support.

If a facility has distributed or transferred affected devices to other facilities, caregivers, or end users, they must promptly notify them of the recall and provide a copy of the notification.

Customers in the US with questions regarding this recall or those experiencing quality problems should contact React Health at 844-698-6276. Adverse reactions or quality problems may also be reported to the FDA MedWatch program.