Medical device recalls Moderate risk

Western/Scott Fetzer Company recalls Western Oxytote DTE Digital VIPR System (with D-size cylinder) Model: MNDS-602

Recall date
October 16, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0269-2022
FDA classification
Class II
Brand / firm
Western/Scott Fetzer Company
Sold / distributed
CT, MD, MT, OH

Why it was recalled

VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to break apart with emission of fumes and smoke

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Western Oxytote DTE Digital VIPR System (with D-size cylinder) Model: MNDS-602

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