Events

Recall of KC 036, KC 060, KC 072 Cuffed Ventilator Tubing

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Instrumentation Industries Inc.

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
    72396
  • Event Risk Class
    Class 2
  • Event Number
    Z-0269-2016
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-11-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140927
  • 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
    Tube, tracheostomy (w/wo connector) - Product Code BTO
  • Reason
    As a distributor of tubing manufactured by smooth bore plastics, we are initiating a product recall for specific lots of kc 036, kc 060 and kc 072 reusable ventilator tubes due to a possible manufacturing defect: a few tubes may have the potential for delamination to occur between the layers of the tube wall which, should it occur, would result in leakage.
  • Action
    Instrumentation Industries notified consignees by e-mail and telephone of the recall. The firm also sent a Notice of Product Recall letter dated September 23, 2015, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were asked to determine if they have any of the affected product and contact the firm to make arrangements for return to Instrumentation Industries, Inc. Replacement product will be sent as soon as possible after all quality inspections have been completed. If product was further distributed consignees were asked to provide recall information to their customers. Customers with questions should call 412-854-1133, ext 433.

Device

KC 036, KC 060, KC 072 Cuffed Ventilator Tubing
  • Model / Serial
    Model Length Lot Numbers KC 036 36 tube P0614015, P0818215, P0825515  KC 060 60 tube P0511915, P0608315 KC 072 72 tube P0618415, P0818515
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including PA, FL, GA, WA, OH, CA, KA and Internationally to Canada.
  • Product Description
    Ventilator Tubing
  • Manufacturer
    Instrumentation Industries Inc

Manufacturer

Instrumentation Industries Inc