Recall Z-2705-2017 ยท JBS Timer, General Laboratory
O-Two Medical Technologies, Inc.
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
| Date | Jun 22, 2017 (initiated Jun 23, 2015) |
| Status | Terminated |
| 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. |
| Root cause | Mixed-up of materials/components |
| 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 rega |
| Quantity | 4382 units (4082 units distributed USA) |
| Distribution | Worldwide Distribution - US (nationwide) Canada, Europe Denmark and Finland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.