FDA Recalls Western Oxytote DTE Digital VIPR System Due to Battery Rupture Risk
Western/Scott Fetzer Company is recalling 40 units of the Oxytote DTE Digital VIPR System due to battery rupture risk. The device may emit fumes and smoke when the battery ruptures and plastic shroud breaks apart.
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 an FDA Class II recall involving a medical device with a battery rupture hazard that could emit fumes and smoke. No injuries or illnesses 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
The U.S. Food and Drug Administration is recalling the Western Oxytote DTE Digital VIPR System, Model MNDS-602, a medical device manufactured by Western/Scott Fetzer Company. A total of 40 units were distributed between May 29, 2020, and August 31, 2021.
The recalled units have a defective battery that may rupture, causing the plastic VIPR shroud to break apart and emit fumes and smoke. This creates a potential hazard to users of the device.
The affected units were distributed to facilities in Connecticut, Maryland, Montana, and Ohio. Consumers can identify unaffected units by a green and silver control knob sticker, which indicates manufacture after August 31, 2021.
Persons using the affected device should be aware of this potential hazard and contact the manufacturer for guidance on replacement or repair.
The recalled product
- Product
- Western Oxytote DTE Digital VIPR System (with D-size cylinder) Model: MNDS-602
- Manufacturer
- Western/Scott Fetzer Company
- Hazard
- battery-rupture
- fumes
- smoke
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:
- CT
- MD
- MT
- OH
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