O-Two Adult Ventilation Timer, MODEL #(s): 01BM1000-CS, 01BM3201-MOTP-CS, 01BM3201-MOTL-CS, CATALOG #(s): 01BM1000 --- I

FDA device recall Z-2705-2017 · posted 2017-06-22 · Terminated

Recall details

Recalling firm

O-Two Medical Technologies, Inc.

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.

Action taken

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

Status

Terminated

Product code

JBS

Quantity affected

4382 units (4082 units distributed USA)

Distribution

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

Date initiated

2015-06-23

Date posted

2017-06-22

Date terminated

2017-09-01

Location

Mississauga, Canada