Events

Recall of Device Recall King systems

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
    70610
  • Event Risk Class
    Class 2
  • Event Number
    Z-1361-2015
  • Event Initiated Date
    2015-02-17
  • Event Date Posted
    2015-04-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-10-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134354
  • 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
    Connector, airway (extension) - Product Code BZA
  • Reason
    Product is mislabeled as double swivel connector with suction port and is actually double swivel connector without suction port. if the incorrect component is not identified prior to clinical use, the incorrect connector would be replaced during the case without risk to the patient and could result in a short delay of the procedure.
  • Action
    Kingsystems sent an Urgent Medical Device Recall letter dated February 17, 2015 to affected customers. The letter identified the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions, call your King Systems customer service representative at 800.642.5464.

Device

Device Recall King systems
  • Model / Serial
    Part number 7169 Lot number 1737171
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide in the states of IL, IN, KY, MI, PA, and TN
  • Product Description
    Double Swivel Connector with Suction Port || Connector, Airway (Extension) || King Systems part 7169 || Product Usage: || An airway connector is a device intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or gas mask. The double swivel connector with suction port is an optional connector for a breathing circuit. King System s offers two versions of the double swivel connector, one with a suction port and one without a suction port. The clinical significance of the suction port is that it provides the caregiver the opportunity to perform a secondary procedure if so desired.
  • 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