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Z-2885-2018 Class II Terminated

Recalled by O-Two Medical Technologies, Inc. — Mississauga

FDA device recall Z-2885-2018 was initiated by O-Two Medical Technologies, Inc. on May 14, 2018 and is designated Class II. Reason for recall: Higher levels of nitrous oxide delivered than specification The recall status is terminated (terminated June 3, 2020). Affected quantity: 3 units.

Recall Details

Product Type
Devices
Report Date
August 29, 2018
Initiation Date
May 14, 2018
Termination Date
June 3, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3 units

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

Distribution Pattern

AK, CA, FL

Code Information

Serial Number: EQ1332-17, EQ3001-18, EQ3003-18

Other recalls by O-Two Medical Technologies, Inc.

  • Z-0977-2019 Class I — e600 Automatic Transport Ventilator, Model Number 01EVE600 (February 12, 2019)
  • Z-0978-2019 Class I — e700 Automatic Transport Ventilator, Model Number 01EVE700 (February 12, 2019)
  • Z-0976-2019 Class I — e500 Automatic Transport Ventilator, Model Number 01EVE500 (February 12, 2019)
  • Z-2731-2017 Class II — Burn Relief¿, MODEL #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200, CATALOG #(s): (September 30, 2015)
  • Z-2705-2017 Class II — O-Two Adult Ventilation Timer, MODEL #(s): 01BM1000-CS, 01BM3201-MOTP-CS, 01BM3 (June 23, 2015)

FDA data resources