Events

Recall of Device Recall Portable Oxygen Conserving Regulator.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Western a Scott Fetzer Co.

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
    27188
  • Event Risk Class
    Class 2
  • Event Number
    Z-0054-04
  • Event Initiated Date
    2003-10-02
  • Event Date Posted
    2003-10-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-01-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29398
  • 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
    Ventilator, Non-Continuous (Respirator) - Product Code BZD
  • Reason
    The demand valve is defective and does not function as intended in the 'conservative mode'.
  • Action
    The firm notified the affected consignees by letter on 10/2/2003. Customers were asked to return the units for replacements.

Device

Device Recall Portable Oxygen Conserving Regulator.
  • Model / Serial
    Unit S/Ns beginning with ''DHE0010xxxxx'' and ''DHE001100001'' thru ''DHE001102881''
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The device was distributed nationwide and into China and Japan.
  • Product Description
    Western Medica OPC Portable Oxygen Conserving Regulator, Model MDL-7609, 1/2 - 5 LPM, packaged under the Medline label.
  • Manufacturer
    Western a Scott Fetzer Co

Manufacturer

Western a Scott Fetzer Co
  • Manufacturer Address
    Western a Scott Fetzer Co, 875 Bassett Rd, Westlake OH 44145
  • Source
    USFDA