Ventec Life Systems, Inc.: VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000

Company / brand

Ventec Life Systems, Inc.

Product

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

Reason / hazard

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

Status

Ongoing

Distribution / sold at

US: OH, GA, CA, MO

Recall initiated

2026-03-25

Code info

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, 152888, 152889, 152890, 152891, 152892, 152893, 152895, 152896, 152897, 152898, 152899, 152900, 152901, 152902, 152903, 152904, 152908, 152909, 152910, 152911, 152912, 152913, 152914, 152915, 152916, 152917, 152918, 152919, 152986, 152987, 155236, 156507, 156512, 156515, 156516, 156517, 156524, 156532

Product quantity

42

Voluntary mandated

Voluntary: Firm initiated

City

Bothell

State

WA

Country

United States

Event id

98554

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