Recall Z-2705-2017— O-Two Medical Technologies, Inc.
Class II · Terminated
Class II FDA medical device recall by O-Two Medical Technologies, Inc., initiated 2015-06-23, terminated 2017-09-01. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. Reason: 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..
- Recalling firm
- O-Two Medical Technologies, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-06-23
- Terminated
- 2017-09-01
- Firm location
- Mississauga, Canada
Product description
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
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.