Devices

React Health Recalls Ventilators Due to Manufacturing Issue

React Health is recalling (Class 1) certain VOCSN V+Pro ventilators due to a manufacturing issue that could lead to undetected oxygen leaks and potentially cause serious injury or death, according to an FDA notice.

The recall affects VOCSN V+Pro Package devices with catalog number PRT-01198-000 and VOCSN V+Pro Unit devices with catalog number PRT-01185-000. The affected devices were manufactured by React’s Ventec unit.

According to FDA, the problem stems from a manufacturing process deviation tied to a production testing configuration error. Certain ventilators may not have been tested under all intended high-pressure conditions, potentially allowing an oxygen leak condition to go undetected, it says.

The agency said the issue could result in delivery of oxygen concentrations below intended levels before or during ventilation. In oxygen-enriched environments, the leak could also increase the risk of fire.

The VOCSN Unified Respiratory System is used to provide continuous or intermittent ventilator support for patients requiring mechanical ventilation in invasive and non-invasive settings, the agency says.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome