Events

Recall of Device Recall DatexOhmeda

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

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
    25632
  • Event Risk Class
    Class 2
  • Event Number
    Z-0714-03
  • Event Initiated Date
    2003-02-12
  • Event Date Posted
    2003-04-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-07-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26243
  • 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
    Absorber, Carbon-Dioxide - Product Code BSF
  • Reason
    Multi absorbers for anesthesia delivery equipment may have missing or damaged filters, exposing the patient to dust from soda lime in the absorbers.
  • Action
    Recall letters dated February 12, 2003 requested that the product be removed from use and returned.

Device

Device Recall DatexOhmeda
  • Model / Serial
    Lot numbers 728112 and 798122 of the Multi Absorbers in the kits
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide in the United States.
  • Product Description
    Multi Absorbers, reference number 8003138, in S/5 Aespire Start-up Kits (each containing 2 Multi Absorbers)
  • Manufacturer
    Datex-Ohmeda

Manufacturer

Datex-Ohmeda
  • Manufacturer Address
    Datex-Ohmeda, 3030 Ohmeda Dr. Box 7550, Madison WI 53707
  • Source
    USFDA