Events

Recall of Device Recall Timer, General Laboratory

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by O-Two Medical Technologies, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    77528
  • Event Risk Class
    Class 2
  • Event Number
    Z-2705-2017
  • Event Initiated Date
    2015-06-23
  • Event Date Posted
    2017-06-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-09-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156266
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Timer, general laboratory - Product Code JBS
  • 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.
  • 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.

Device

Device Recall Timer, General Laboratory
  • Model / Serial
    Lot #s: 079810; 078734, 081071, 140411, 141117, 140719, 140506, 130117 Expiration date: Jul.2016
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) Canada, Europe Denmark and Finland
  • Product Description
    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
  • Manufacturer
    O-Two Medical Technologies, Inc.

Manufacturer

O-Two Medical Technologies, Inc.
  • Manufacturer Address
    O-Two Medical Technologies, Inc., 7575 Kimbel Street, Mississauga Canada
  • Manufacturer Parent Company (2017)
    O-Two Medical Technologies Inc
  • Source
    USFDA