HIGH

VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000

Respiratory system intended to provide continuous/intermittent ventilator support, may not have been evaluated under all intended high-pressure conditions during production testing, so an oxygen leak condition could occur that may lead to reduced below intended levels of fraction of inspired oxygen delivery prior to and during ventilation and this oxygen-enriched environment may increase fire risk

Quick Facts at a Glance

Recall Date
March 25, 2026
Hazard Level
HIGH
Brand
Ventec Life Systems
Geographic Scope
4 states

Hazard Information

Respiratory system intended to provide continuous/intermittent ventilator support, may not have been evaluated under all intended high-pressure conditions during production testing, so an oxygen leak condition could occur that may lead to reduced below intended levels of fraction of inspired oxygen delivery prior to and during ventilation and this oxygen-enriched environment may increase fire risk

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Ventec Life Systems, Inc. or your healthcare provider for instructions

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Full Description

VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000. Reason: Respiratory system intended to provide continuous/intermittent ventilator support, may not have been evaluated under all intended high-pressure conditions during production testing, so an oxygen leak condition could occur that may lead to reduced below intended levels of fraction of inspired oxygen delivery prior to and during ventilation and this oxygen-enriched environment may increase fire risk. Classification: Class I. Quantity: 42. Distribution: US: OH, GA, CA, MO

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: How to Get Refunds and Replacements

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Product Classification

Product Details

Model Numbers
UDI-DI (REF/UDI-DI): PRT-01198-000/00855573007914
PRT-01185-000/00855573007877 Package/Device Serial Number (package serial number may include a "P" at the end): 152884
152885
152886
152887
+15 more
Affected States
OH, GA, CA, MO
Report Date
May 13, 2026
Recall Status
ACTIVE