Events

Recall of Device Recall KING LTS D, Size 3, 100025 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
    54350
  • Event Risk Class
    Class 2
  • Event Number
    Z-0977-2011
  • Event Initiated Date
    2009-12-15
  • Event Date Posted
    2011-01-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88831
  • 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
    King systems was issued a warning letter from the center for devices and radiological health, office of compliance on october 28, 2009. the warning letter asserts that kings systems klt(s)-d airway exceeds cleared indications in that it is promoted for "airway management in patients over 4 feet in height, for controlled or spontaneous ventilation, difficult and emergent airway cases, and ambulat.
  • Action
    On October 29, 2009, the firm, Kings System, sent a "Urgent - Product Correction" letter to the customers. The letter described the product, problem and actions to be taken. The customers were instructed to remove the promotional material from the King System website which includes literature, and Instructions for Use. The firm instructed all Sales force and distributors to cease dissemination of promotional materials, literature and communications. Note: The firm revised indications, instructions for use, product labels and labeling so it is aligned with the 510Ks. The customers were also instructed to replace current instructions for use with revised instructions for use and destroy the current IFU; return Kings LT(S)-D oropharyngeal airway product inventory to King Systems; and complete and return the attached Instructions for Use Destruction Signature Form via fax to King Systems at 317-776-5197. For further information, please call 317-776-6823 ext 257 or email: LTSD@kingsystem.com.

Device

Device Recall KING LTS D, Size 3, 100025 Oropharyngeal Airway
  • Model / Serial
    all product produced prior to 12/2009.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA and countries including: Canada, Costa Rica, and Panama.
  • Product Description
    KING LTS -D, Size 3, 10-0025, Oropharyngeal Airway. King Systems Corporation, 15011 Herriman Boulevard, Noblesville, IN 46060. || Intended use: Airway management by providing a patent airway to allow patient ventilation.
  • 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