Recall Z-0268-2022— Western/Scott Fetzer Company
Class II · Ongoing
Class II FDA medical device recall by Western/Scott Fetzer Company, initiated 2021-10-16. FDA's recall record names no specific 510(k) clearance for this event. Product: Western Oxytote DTE Digital VIPR (head only) Model: MNDR-600. Reason: VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to break apart with emission of fumes and smoke.
- Recalling firm
- Western/Scott Fetzer Company
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-10-16
- Firm location
- Westlake, OH, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.