Events

Recall of Flow Meter, CM Assembly

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Accutron 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
    63174
  • Event Risk Class
    Class 1
  • Event Number
    Z-0017-2013
  • Event Initiated Date
    2012-04-29
  • Event Date Posted
    2012-10-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-02-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112796
  • 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
    Gas-machine, anesthesia - Product Code BSZ
  • Reason
    Accutron is recalling the flowmeter (analgesia gas machine) because when it flows nitrous gas without oxygen gas being turned on, it functions in an incorrect manner.
  • Action
    Accutron sent an Urgent Advisory Notice letter dated April 6, 2012 to all their customers who purchased the Ultra PC% Cabinet Mount Flowmeter. The letter informed the customers of the problem identified and actions to be taken. Customers were instructed to discontinue use or to continue use of the device only with extreme care until a replacement can be installed. Extreme care includes the use of the titration method for nitrous oxide administration coupled with close monitoring of both the patient and the actual gas flow through the flowtubes. For question contact Accutron at (800) 531-2221 or by email at jheadrick@accutron-inc.com.

Device

Flow Meter, CM Assembly
  • Model / Serial
    Model#27025: Lot # 73971, 74929.  Model#31970: Lot#74142.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    Flow Meter, CM Assembly, Model #27025, Serial # 13686, 13690, 13712, 13793. || Flowmeter, CM Assembly, Model#31970, Serial#13692. || Product Usage: || Conscious Sedation Unit Analgesia Gas Machine.
  • Manufacturer
    Accutron Inc

Manufacturer

Accutron Inc
  • Manufacturer Address
    Accutron Inc, 1733 W Parkside Ln, Phoenix AZ 85027-1382
  • Manufacturer Parent Company (2017)
    Cantel Medical Corp.
  • Source
    USFDA