Events

Recall of Device Recall King LTSD

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
    66189
  • Event Risk Class
    Class 2
  • Event Number
    Z-0002-2014
  • Event Initiated Date
    2012-12-13
  • Event Date Posted
    2013-10-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-11-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121688
  • 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
    On december 13, 2012, king systems initiated a voluntary recall of one (1) case(s) (5) individual products) from one (1) lot [(iv1v3) 62 cases, 310 products]of king ltsd oropharyngeal airways because the package label indicated that the airway was a size 5 when in fact the airway in the package was a size 4. when king manufacturers a lot, all of the components are the same size, part number etc. i.
  • Action
    King Systems notified the only one (1) consignee who received the affected product of the problem via a customer complaint. Five (5) of the five (5) affected products were destroyed by consignee.

Device

Device Recall King LTSD
  • Model / Serial
    Part Number(s): KLTSD415 Lot Number(s): IV1V3
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    USA Nationwide Distribution in the state of NY
  • Product Description
    King LTS-D Oropharyngeal Airways || Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.
  • 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