Events

Recall of Device Recall KING LAD SILI CONE

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
    63580
  • Event Risk Class
    Class 2
  • Event Number
    Z-0422-2013
  • Event Initiated Date
    2012-11-02
  • Event Date Posted
    2012-11-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-05-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114243
  • 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 firm received two complaints from a user facility in new jersey regarding color-coded eto sterilization indicators on the primary device packaging that did not undergo the expected color change. the complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an eto.
  • Action
    King Systems sent an URGENT MEDICAL DEVICE RECALL NOTIFICATION letter dated October 31, 2012 to all affected consignees via email. The letter identified affected product, problem and actions to be taken. The letter states that further use and/or distribution of any remaining product affected by this recall should cease immediately. The letter instructs customers to destroy all of the affected products and indicate the destruction by signing and returning the attached forms using the enclosed self-addressed envelope. For questions contact your King Systems customer service representative at 800-642-5464.

Device

Device Recall KING LAD SILI CONE
  • Model / Serial
    REF: LAD-703, Lot #K120411
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution - WI, TX, NY, MO, IN, KY, FL, NJ, PA, TN, and NC
  • Product Description
    KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie10 devices/case || Size 3 / Child ClearSeal King LAD¿ Patient Size: 30-50kg || Product Usage: || Laryngeal 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