Events

Recall of King LTD Oropharyngeal Airways

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
    66185
  • Event Risk Class
    Class 3
  • Event Number
    Z-2255-2013
  • Event Initiated Date
    2013-09-03
  • Event Date Posted
    2013-09-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-04-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121670
  • 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
    Report that size 5 kltd airways were packaged in pouches indicating a size of 2.5 and shipped to your facility. the correct size of the kltd airway is clearly marked on the actual airway product and the physical size difference between 2.5 and 5 is distinct and obvious.
  • Action
    King Systems notified one consignee who received the affected product verbally on August 7, 2013, via email and an Urgent Medical Device Recall - Immediate Action Required notification on September 3, 2013. The Urgent Medical Device Recall - Immediate Action Required notification described the product and issue as well as includes a response form for the consignee to complete and send back to King Systems via FAX to 317-776-5175, or email to wnet@ambu.com. Questions regarding the notice are directed to: King Systems customer service representative at 800.642.5464, Monday through Friday 8:00am- 5pm EDT. For questions regarding this recall call 317-776-6823.

Device

King LTD Oropharyngeal Airways
  • Model / Serial
    Part Number KLTD2125 Lot Number I10RG
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed in NY.
  • Product Description
    King LT-D Oropharyngeal Airways || The King LT-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