FDA recall Z-2885-2018
O-Two Medical Technologies, Inc. · Class II · device
Product
O-Two Equinox¿ Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Model#: 01EQ1000
Reason for recall
Higher levels of nitrous oxide delivered than specification
Distribution
AK, CA, FL
Key facts
- Status
- Terminated
- Initiation date
- 2018-05-14
- Report date
- 2018-08-29
- Termination date
- 2020-06-03
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Mississauga, Canada
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2885-2018