Events

Recall of Device Recall 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
    66184
  • Event Risk Class
    Class 1
  • Event Number
    Z-2272-2013
  • Event Initiated Date
    2012-08-23
  • Event Date Posted
    2013-09-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-11-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121659
  • 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
    Circuit, breathing (w connector, adaptor, y piece) - Product Code CAI
  • Reason
    King systems received a customer complaint indicating that the customer had ordered a breathing circuit with a latex breathing bag. the product they received contained a latex breathing bag, but was labeled as non-latex.
  • Action
    Ambu, Inc. sent a letter dated June 24, 2013, informing the customer that they have decided to discontinue the manufacture and sales of the King Systems latex breathing bags and to conver all customers to their King Systems latex-free breathing bags. The customer was advised to adjust their inventories accordingly and transition to the latex free part number as their inventory levels reach their minimums. For questions the customer was advised to call 317-403-8677. For questions regarding this recall call 317-776-6823.

Device

Device Recall Universal Flex2 Breathing Circuit
  • Model / Serial
    Part Number DF4110-61 Lot Number I063N
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution - NE only.
  • Product Description
    Universal Flex2 Breathing Circuit || Class I || 510(k) Exempt || An anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece.
  • Manufacturer
    King Systems Corp.

Manufacturer

King Systems Corp.
  • Manufacturer Address
    King Systems Corp., 15011 Herriman Blvd, Noblesville IN 46060-4253
  • Manufacturer Parent Company (2017)
    Vsri Holding Ii Aps
  • Source
    USFDA