The Recall Desk
HighFDA (Devices)·Z-0270-2022·Announced 2021-12-01

Western Oxytote VIPR System Battery Rupture Risk with Fume Emission

Western/Scott Fetzer Company is recalling 40 units of the Western Oxytote DTE Digital VIPR System due to battery rupture risk that can break the plastic shroud and release fumes and smoke.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a risk-of-harm medical device where battery rupture with fume and smoke emission presents an inhalation hazard. No illnesses or injuries have been reported. Per the severity rubric, risk-of-harm products where injury has not yet been reported score as High (3).

Plain-English summary

Western/Scott Fetzer Company is recalling the Western Oxytote DTE Digital VIPR System (Model MNDS-603), a medical device with a Valve Integrated Pressure Regulator (VIPR). The recall affects 40 units distributed to medical facilities in Connecticut, Maryland, Montana, and Ohio between May 29, 2020 and August 31, 2021.

The recall is due to a battery rupture hazard in the VIPR component. The internal battery can rupture, causing the plastic VIPR shroud to break apart and release fumes and smoke.

Units manufactured after August 31, 2021 are not part of this recall and can be identified by a green and silver control knob sticker.

The recalled product

Product
Western Oxytote DTE Digital VIPR System (with E-size cylinder) Model: MNDS-603
Manufacturer
Western/Scott Fetzer Company
Category
Medical Device — Respiratory Equipment
Hazard
Affected units
40

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • silver background)

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 4 recalled by Western/Scott Fetzer Company under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · Western/Scott Fetzer Company

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Same hazard · battery rupture

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