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Recall Observatory FDA recall evidence

Device product

Western Oxytote DTE Digital VIPR (head only) Model: MNDR-600

Z-0268-2022

October 16, 2021

Class II

Product summary

Firm
Western/Scott Fetzer Company
Event
Event 88877
Status
Ongoing
Classification
Class II
Quantity
4974 units
Official record key
device-enforcement:Z-0268-2022

Official wording

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

Code information: Units distributed from 05/29/20 to 08/31/21. Digital VIPR units manufactured and distributed after 08/31/21 are outside the scope of this recall and will be recognized by a green and silver control knob sticker (green logo, silver background)

Distribution pattern: CT, MD, MT, OH

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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