Z-2705-2017 Class II Terminated
FDA device recall Z-2705-2017 was initiated by O-Two Medical Technologies, Inc. on June 23, 2015 and is designated Class II. 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. The recall status is terminated (terminated September 1, 2017). Affected quantity: 4382 units (4082 units distributed USA).
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