Z-2705-2017Class II

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

Name: Z-2705-2017 O-Two Adult Ventilation Timer, MODEL #(s): 01BM1000-CS, 01BM3201-MOTP-CS, 01BM3201-MOTL-CS, CATALOG #(s)...
Creator: O-Two Medical Technologies, Inc.
Published: 2015-06-23
License: https://open.fda.gov/license/

O-Two Medical Technologies, Inc. / initiated 2015-06-23 / Terminated / root cause: labeling and UDI

FDA source

O-Two Medical Technologies, Inc. began a recall of O-Two Adult Ventilation Timer, MODEL #(s): 01BM1000-CS, 01BM3201-MOTP-CS, 01BM3201-MOTL-CS, CATALOG #(s): 01BM1000 --- INTENDED USE: The Adult Ventilation... on 2015-06-23. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2705-2017
Classification: Class II
Status: Terminated
Initiated: 2015-06-23
Posted: 2017-06-22
Terminated: 2017-09-01
Recalling firm: O-Two Medical Technologies, Inc.
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
Product code: JBS Timer, General Laboratory
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.
Root cause tag: labeling and UDI
FDA 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 regarding this recall call 905-677-9410 or 1-800-387-3405.
Quantity in commerce: 4382 units (4082 units distributed USA)
Distribution: Worldwide Distribution - US (nationwide) Canada, Europe Denmark and Finland
Product codes and lots: Lot #s: 079810; 078734, 081071, 140411, 141117, 140719, 140506, 130117 Expiration date: Jul.2016

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2705-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2705-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-19	2017-07-10

Product code JBS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)