FDA Recall
Terminated
O-Two Equinox Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Model#: 01EQ1000
Recall: Z-2885-2018
·
Initiated May 14, 2018
Recall
- Recall Number
- Z-2885-2018
- Event Number
- 80414
- Firm
- O-Two Medical Technologies, Inc.
- FEI Number
- 3002807836
- Product Code
- BZR
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- May 14, 2018
- Terminated
- June 3, 2020
- Address
- 7575 Kimbel Street, Mississauga Canada
Description
O-Two Equinox Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Model#: 01EQ1000
Reason
Higher levels of nitrous oxide delivered than specification
Action
O-Two Medical Technologies Inc. issued letter on May 14. 2018 titled: Notice of Product Upgrade of the 0-Two Equinox Relieve Analgesic Gas Delivery System , requesting customers to return their units for inspection and upgrade. Contact via email to [email protected].
Distribution
AK, CA, FL
Quantity
3 units