Events

Recall of Device Recall accessory to ABL800 Flex

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Radiometer America 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
    38511
  • Event Risk Class
    Class 2
  • Event Number
    Z-0038-2008
  • Event Initiated Date
    2007-06-22
  • Event Date Posted
    2007-10-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53878
  • 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
    Pump Tube, Waste - Product Code CHL
  • Reason
    Tube may break. the firm discovered that the yellowish/white tubes used in their blood gas analyzers (abl800 flex series) were manufactured incorrectly. these tubes have the potential to break off at the black plastic connectors. the breakage may occur during the installation of the tubes or after a short time in use.
  • Action
    By telephone call or service representative visit beginning July 18, 2007, Consumers/End Users are asked to locate the analyzers and yearly service kits concerned and replace all pump tubes with new ones.

Device

Device Recall accessory to ABL800 Flex
  • Model / Serial
    Serial #905-671, 902-754
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed throughout the United States and Canada.
  • Product Description
    Pump waste tube for blood gas analysis kit. One yellowish/white rubber tube per plastic bag. Used on ABL800 Flex Series blood gas analyzers.
  • Manufacturer
    Radiometer America Inc

Manufacturer

Radiometer America Inc
  • Manufacturer Address
    Radiometer America Inc, 810 Sharon Dr, Westlake OH 44145-1598
  • Source
    USFDA