Events

Recall of Device Recall King LT(S)D Oropharyngeal Airway

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
    57810
  • Event Risk Class
    Class 2
  • Event Number
    Z-1879-2011
  • Event Initiated Date
    2011-01-24
  • Event Date Posted
    2011-04-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97483
  • 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
    Airway, oropharyngeal, anesthesiology - Product Code CAE
  • Reason
    The firms contract manufacturer reported that the products were below the specification for hardness. this could contribute to a higher incidence of problems during the insertion and final positioning of the airway in the patient. in rare instances the softness of the tube could cause the tube to fold over.
  • Action
    King Systems Corp. sent an URGENT DEVICE RECALL NOTICE letter dated January 24, 2011, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. The letters instructed users to cease all sales of the recalled product, to notify the consignees for any product that was further distributed, and to return all recalled product to King Systems. The notice did include a response form. For questions call 317-776-6823, ext 257.

Device

Device Recall King LT(S)D Oropharyngeal Airway
  • Model / Serial
    201011-169
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA and Canada
  • Product Description
    King System , King LTS-D Kit Size 5, Sterile, REF KLTSD405, Manufacturer: King Systems Noblesville, IN. || Ventilation during anesthesia during procedures of short duration. An oropharyngeal airway is a device inserted through the mouth to provide a patent airway.
  • 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