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Recall Observatory FDA recall evidence

Device 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

Z-2705-2017

June 23, 2015

Class II

Product summary

Firm
O-Two Medical Technologies, Inc.
Event
Event 77528
Status
Terminated
Classification
Class II
Quantity
4382 units (4082 units distributed USA)
Official record key
device-enforcement:Z-2705-2017

Official wording

Reason: 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.

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.