Home / Recalls / O-Two Medical Technologies, Inc. / Z-2731-2017

Z-2731-2017 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
July 19, 2017
Initiation Date
September 30, 2015
Termination Date
September 1, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
624 units

Product Description

Burn Relief¿, MODEL #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200, CATALOG #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200 --- DRESSING,WOUND,HYDROGEL W/OUT DRUG AND/OR BIOLOGIC. --- Burn Relief¿ products are self-cooling, non-adhering and are intended to be used on 1st and 2nd degree burns.

Reason for Recall

For lack of evidence to validate effectiveness of sterilization dose, O-Two Medical Technologies Inc. hereby announces a voluntary medical device recall of the suspected batches of Burn Relief¿ products to prevent potential contamination. .

Distribution Pattern

Worldwide Distribution - US (nationwide) Canada, Belgium, Norway, and Malaysia

Code Information

Lot/Batch#1150, 1152, 5210; Expiration date: Jul.2018 (for lot 5210), July 2020 (for lot 1150, 1152)

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-2885-2018 Class II — O-Two Equinox¿ Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Model#: (May 14, 2018)
  • Z-2705-2017 Class II — O-Two Adult Ventilation Timer, MODEL #(s): 01BM1000-CS, 01BM3201-MOTP-CS, 01BM3 (June 23, 2015)