Recall Z-2885-2018— O-Two Medical Technologies, Inc.
Class II · Terminated
Class II FDA medical device recall by O-Two Medical Technologies, Inc., initiated 2018-05-14, terminated 2020-06-03. It names one FDA 510(k) clearance: K113687. Product: O-Two Equinox¿ Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Model#: 01EQ1000. Reason: Higher levels of nitrous oxide delivered than specification.
- Recalling firm
- O-Two Medical Technologies, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-05-14
- Terminated
- 2020-06-03
- Firm location
- Mississauga, Canada
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.