Events

Recall of Device Recall King Systems KLTSD414 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
    66869
  • Event Risk Class
    Class 2
  • Event Number
    Z-0709-2014
  • Event Initiated Date
    2013-12-13
  • Event Date Posted
    2014-01-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-05-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124329
  • 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
    Kltd214 airways found inside kltsd414 packages. the kltsd414 airway has a lumen for use of a gastric suction tube; the kltd214 airway does not include a lumen for a gastric suction tube.
  • Action
    December 13, 2013 Urgent Recall Notices were sent to all Direct Accounts identifying the recalled item, risks associated with the incorrectly labeled product and asking customers to stop use, quarantine and destroy any recalled product on hand. Customers were asked to froward the notifcation if the product was further distributed and FAX the completed recall acknowledgement form to 317-776-5175 or email wnethercutt@kingsystems.com. Call the customer service representative (800.262.8673) to arrange for credit of your affected product(s).

Device

Device Recall King Systems KLTSD414 airway
  • Model / Serial
    Lot Number(s): I15LB
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed in the states of CA, NY
  • Product Description
    King Systems || KLTSD414 || Quantity, 5 PER CASE KING LTSD || KIT SIZE 4 || King LT(S)-DTM || supraglottic airway || Identification Part Number(s): KLTSD414 || KING LTSD KIT/KIT/TROUSSE/KIT SIZE 4 || Contents: 1 - KLTSD Size 4......(155 - 180cm) .. 1 - 60cc Syringe 1 - Sterile || Lubricant 32-5332 05/10 || Intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration.
  • 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