Events

Recall of King Systems, DatexOhmeda, Universal Flex2 Breathing Circuit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by King Systems 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
    48991
  • Event Risk Class
    Class 2
  • Event Number
    Z-0676-2009
  • Event Initiated Date
    2008-08-01
  • Event Date Posted
    2009-02-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-11-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75574
  • 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
    Breathing Circuit - Product Code CAI
  • Reason
    The inner line may be severed or broken into two pieces, thus hindering the delivery of oxygen and anesthetics to the patient and possibly elevated patient carbon dioxide levels.
  • Action
    Consignees were notified by an Urgent Product Recall letter on or about 7/29/2008 to cease sales, notify their customers to the hospital level, and to return product on hand.

Device

King Systems, DatexOhmeda, Universal Flex2 Breathing Circuit
  • Model / Serial
    Lots IKAM3, IKC63, IKIG0, IKMB9, IKRH0, IKV71, ILO78 and IL2P7.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - including USA and countries of Australia, Colombia, Germany, Netherlands, and Peru.
  • Product Description
    King Systems, Datex-Ohmeda, Universal Flex2 Breathing Circuit, Latex Free, 50 per case, King Systems Corporation, Noblesville, IN; REF # CP-05207. || This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation.
  • Manufacturer
    King Systems Corp.

Manufacturer

King Systems Corp.
  • Manufacturer Address
    King Systems Corp., 15011 Herriman Blvd, Noblesville IN 46060
  • Manufacturer Parent Company (2017)
    Vsri Holding Ii Aps
  • Source
    USFDA