Events

Recall of Device Recall Medline EndurO2 Oxygen Concentrator with Oxygen Monitor

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medline Industries 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
    47225
  • Event Risk Class
    Class 2
  • Event Number
    Z-1473-2008
  • Event Initiated Date
    2008-03-04
  • Event Date Posted
    2008-07-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-06-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69063
  • 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
    Portable Oxygen Generator - Product Code CAW
  • Reason
    Overheating of components: there is the potential for an electrical component in the oxygen concentrator to overheat, causing damage to the unit and making it nonfunctional.
  • Action
    Consignees were notified by a letter sent on 3/4/08. The letter informed users that the recalling firm will replace the affected units with new units or issue a credit for the returned recalled units. Distributors were requested to notify their accounts of the recall. The letter requested users to complete and return an enclosed response sheet, indicating the number of units to be replaced or returned for credit. For additional information, contact 866-359-1704.

Device

Device Recall Medline EndurO2 Oxygen Concentrator with Oxygen Monitor
  • Model / Serial
    Reorder Number: HCS02; All units produced since July 2006.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Medline EndurO2 Oxygen Concentrator with Oxygen Monitor; Portable oxygen generator; Reorder Number: HCS02; Packaged in 1 unit per case; Product is an oxygen generator designed to provide oxygen to patient who has been prescribed oxygen therapy by a physician.
  • Manufacturer
    Medline Industries Inc

Manufacturer

Medline Industries Inc
  • Manufacturer Address
    Medline Industries Inc, 1 Medline Pl, Mundelein IL 60060-4486
  • Source
    USFDA