Z-2705-2017 Class II Terminated

Recalled by O-Two Medical Technologies, Inc. — Mississauga

Recall Details

Product Type
Devices
Report Date
July 19, 2017
Initiation Date
June 23, 2015
Termination Date
September 1, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4382 units (4082 units distributed USA)

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.

Distribution Pattern

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

Code Information

Lot #s: 079810; 078734, 081071, 140411, 141117, 140719, 140506, 130117 Expiration date: Jul.2016