FDA-Device2017-07-19Class II
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
O-Two Medical Technologies, Inc.
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.
Sold states
Worldwide Distribution - US (nationwide) Canada, Europe Denmark and Finland
Affected count
4382 units (4082 units distributed USA)
Manufactured in
7575 Kimbel Street, Mississauga, Canada
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2705-2017Don't want to check this manually?
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