Z-0268-2022 Class II Ongoing
FDA device recall Z-0268-2022 was initiated by Western/Scott Fetzer Company on October 16, 2021 and is designated Class II. Reason for recall: VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to break apart with emission of fumes and smoke The recall status is ongoing. Affected quantity: 4974 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 1, 2021
- Initiation Date
- October 16, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4974 units
Product Description
Western Oxytote DTE Digital VIPR (head only) Model: MNDR-600
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 Pattern
CT, MD, MT, OH
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)