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Terminated

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

FDA Recall Z-2705-2017 · Posted 2017-06-22

Recall StatusTerminated
Product CodeJBS
Date Initiated2015-06-23
Date Terminated2017-09-01
Product Quantity4382 units (4082 units distributed USA)

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.

Firm Action

O-Two Medical Technologies sent a Recall Notification on June 23, 2015, to all affected customers. The letter notified customers of the malfunctioning device, description, brand name, model/catalog number, target population, quantity, Lot Number, Shelf Life, hazard potential, and an image of labeling. The letter also provided instructions to customer for action and response. Customers were to return the affected product and O-Two will ship back the unaffected medical devices. Customers were instructed to acknowledge receipt of this recall notice by fax to 1-905-677-2035. For questions regarding this recall call 905-677-9410 or 1-800-387-3405.

Root Cause

Mixed-up of materials/components

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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