Events

Recall of Bayer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bayer Corp..

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
    27414
  • Event Risk Class
    Class 2
  • Event Number
    Z-0066-04
  • Event Date Posted
    2003-10-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-02-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29836
  • 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
    Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph - Product Code CHL
  • Reason
    Potential for bias shift in po2 values due to air bubble in sample path.
  • Action
    Bayer notified each customer by telephone and followed with a FedEx letter dated 9/26/03 providing upgraded software version 3.1 to install .

Device

Bayer
  • Model / Serial
    Software Versions below 3.1
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Foreign: Australia, Austria, Belgium. Canada, France, Germany, Italy, Japan, Korea, Mexico, Netherlands, Russia, S Ireland, Spain, Switzerland
  • Product Description
    Bayer Rapidpoint 405 Blood Gas Analyzer
  • Manufacturer
    Bayer Corp.

Manufacturer

Bayer Corp.
  • Manufacturer Address
    Bayer Corp., 63 North Street, Medfield MA 02052-1688
  • Source
    USFDA