Class 2 Device Recall Equinox Relieve

• Date Initiated by Firm: May 14, 2018
• Create Date: August 22, 2018
• Recall Status: Terminated 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
• FEI Number: 3002807836
• 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: 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