| |
Class 2 Device Recall Equinox Relieve |
 |
| Date Initiated by Firm |
May 14, 2018 |
| Create Date |
August 22, 2018 |
| Recall Status1 |
Terminated 3 on June 03, 2020 |
| Recall Number |
Z-2885-2018 |
| Recall Event ID |
80414 |
| 510(K)Number |
K113687
|
| Product Classification |
Mixer, breathing gases, anesthesia inhalation - Product Code BZR
|
| Product |
O-Two Equinox¿ Relieve N2O/O2 Analgesic Gas Mixing and Delivery System
Model#: 01EQ1000
|
| Code Information |
Serial Number: EQ1332-17, EQ3001-18, EQ3003-18 |
Recalling Firm/
Manufacturer |
O-Two Medical Technologies, Inc.
7575 Kimbel Street
Mississauga Canada
|
Manufacturer Reason
for Recall |
Higher levels of nitrous oxide delivered than specification
|
FDA Determined
Cause 2 |
Device Design |
| 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 david@otwo.com. |
| Quantity in Commerce |
3 units |
| Distribution |
AK, CA, FL |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database |
510(K)s with Product Code = BZR and Original Applicant = O-TWO MEDICAL TECHNOLOGIES, INC.
|
|
|
|
