O-Two Medical Technologies, Inc. Recalls
Showing 1-3 of 3 recalls
O-Two Equinox Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Model#: 01EQ1000
Higher levels of nitrous oxide delivered than specification
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.
O-Two Adult Ventilation Timer, MODEL #(s): 01BM1000-CS, 01BM3201-MOTP-CS, 01BM3201-MOTL-CS, CATALOG #(s): 01BM1000 --- INTENDED USE: The Adult Ventilation Timer is intended to guide the rescuer to provide ventilations at a rate appropriate for adult patients
Malfunction of an O-Two Adult Ventilation Timer, where the flash rate of the malfunctioning device was reported to be twice that of the rate noted on the label.
O-Two Medical Technologies sent a Recall Notification on June 23, 2015, to all affected customers. The letter notified customers of the malfunctioning device, description, brand name, model/catalog number, target population, quantity, Lot Number, Shelf Life, hazard potential, and an image of labeling. The letter also provided instructions to customer for action and response. Customers were to return the affected product and O-Two will ship back the unaffected medical devices. Customers were instructed to acknowledge receipt of this recall notice by fax to 1-905-677-2035. For questions regarding this recall call 905-677-9410 or 1-800-387-3405.
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.
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. .
O-Two sent a Voluntary Recall Notification dated September 30, 2015, to all affected customers. Customers were instructed to acknowledge receipt of the recall notice by fax to 1-905-677-2035; or email to cs@otwo.com. Customers with questions should call 1-905-677-9410. For questions regarding this recall call 905-677-9410 .