Events

Recall of Device Recall RTC 25C Inline Aerosol Tee Adapter

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
    66902
  • Event Risk Class
    Class 2
  • Event Number
    Z-0606-2014
  • Event Initiated Date
    2013-11-13
  • Event Date Posted
    2013-12-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-07-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124096
  • 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
    Circuit, breathing (w connector, adaptor, y piece) - Product Code CAI
  • Reason
    Some packages of the rtc 25-c may have been shipped to customers with incomplete installation and usage directions due to a printing error.
  • Action
    A recall notification letter, dated November 13, 2013, was sent to Users.

Device

Device Recall RTC 25C Inline Aerosol Tee Adapter
  • Model / Serial
    multiple lots shipped between 10/7/13 and 11/6/13: P1002913, P1004413, P1005713, P1007713, P1009813, P1014213, P1014813, and P1102013.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    RTC 25-C Inline Aerosol Tee Adapter. || Intended to be used to adapt an aerosolized medication delivery system having an elliptical mouthpiece to a ventilator circuit.
  • Manufacturer
    Instrumentation Industries Inc

Manufacturer

Instrumentation Industries Inc