FDA recall Z-2705-2017

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 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.

Distribution

Worldwide Distribution - US (nationwide) Canada, Europe Denmark and Finland

Key facts

Status

Terminated

Initiation date

2015-06-23

Report date

2017-07-19

Termination date

2017-09-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mississauga, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2705-2017