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O-Two Medical Technologies, Inc. recalls O-Two Adult Ventilation Timer, MODEL #(s): 01BM1000-CS, 01BM3201-MOTP-CS, 01BM3201-MOTL-CS, CATALOG #(s): 01BM1000 ---
Recalled July 19, 2017 · FDA recall Z-2705-2017 · O-Two Medical Technologies
Hazard
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. · FDA Class II
Units
4382 units (4082 units distributed USA)
Sold at
Worldwide Distribution - US (nationwide) Canada, Europe Denmark and Finland
Description
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.
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
Manufacturer(s)
O-Two Medical Technologies, Inc.
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →