Events

Recall of Device Recall Face Tent with 15 mm Adapter

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
    57972
  • Event Risk Class
    Class 2
  • Event Number
    Z-1888-2011
  • Event Initiated Date
    2011-01-24
  • Event Date Posted
    2011-04-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97884
  • 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
    Oxygen Mask - Product Code BYG
  • Reason
    The firm is conducting a subrecall of facetent masks because the masks could have a sticky substance on the inside or outside of the mask that may manifest itself 6-8 months after the manufacture date of the product. the sticky substance could result in inconvenience or in some remote cases cause patient harm.
  • Action
    The firm issued an URGENT PRODUCT RECALL letter dated 1/24/2011. The letter identified the affected product and stated the reason for recall. The letter instructed consignees to cease all sales, to immediately examine their inventory, and to quarantine the product. The letter included a response form that is to be completed and returned. Distributors were instructed to inform their customers of the recall. King Systems Customer Service Department should be contacted at 1-800-642-5464 in order to receive a Return Authorization Number. The letter stated that consignees should return the recalled products to King Systems and the firm will replace the products or provide an acceptable substitute. Customers should contact Customer Service if they have any questions regarding the recall and the letter.

Device

Device Recall Face Tent with 15 mm Adapter
  • Model / Serial
    IPCF2, IQ3Y0, IQ698, IQPU1, IQUZ0, IR2I7, IRFY3, ISEX6, ISJN6 and IT3Q0.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- NM, GA, TX, FL, IL, VA and LA.
  • Product Description
    Face Tent with 15 mm Adapter, REF S-MD126, Manufacturer: King Systems Nobleville, IN. || An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols.
  • 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