FDAFDA · Food and drugs·Recall number Z-2705-2017
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
Published July 19, 2017 · Recall initiated: June 23, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- O-Two Medical Technologies, Inc.
- Distributor
- Worldwide Distribution - US (nationwide) Canada, Europe Denmark and Finland
- Lot
- Lot #s: 079810; 078734, 081071, 140411, 141117, 140719, 140506, 130117 Expiration date: Jul.2016
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Canada
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