FDA recall Z-0269-2022

Western/Scott Fetzer Company · Class II · device

Product

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

Reason for recall

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

Distribution

CT, MD, MT, OH

Key facts

Status
Ongoing
Initiation date
2021-10-16
Report date
2021-12-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Westlake, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0269-2022