Events

Recall of Device Recall Transtracheal (Jet Ventilation) Catheter ACU 1060.1

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
    52898
  • Event Risk Class
    Class 2
  • Event Number
    Z-2010-2009
  • Event Initiated Date
    2009-07-09
  • Event Date Posted
    2009-09-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-10-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84244
  • 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
    User instructions not updated to correspond with product change.
  • Action
    Instrumentation Industries, Inc. issued a notification letter dated July 9, 2009 to their customers explaining the problem and the need to replace current inventory user instructions with the revised user instructions accompanying the letter. For further questions, contact Instrumentation Industries, Inc. at 1-800-633-8577.

Device

Device Recall Transtracheal (Jet Ventilation) Catheter ACU 1060.1
  • Model / Serial
    Lot Numbers: P0207409, P0209509, P0211009, P0214009, P0215609, P0301609, P0303109, P0304909, P0306209, P0307909, P0312309, P0400209, P0402409, P0404409, P0405909, P0408509, P0410009, P0412209, P0414209, P0416909, P0506509, P0506509R09, P0507609, P0509709, P0515009, P0602309, P0602809, P0604009, P0604209, P0607009, P0607009, P0607009R09, P0608809, P0612309, P0613709, P0615809, P0617309 and P0619209.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- AK, AL, AR, CA, CO, FL, GA, IA, ID, IL,IN, MA, MD, ME, MI, MN, NC, ND, NH, NJ, OH, PA, SC, SD, TX, VA and WA.
  • Product Description
    Transtracheal (Jet Ventilation) Catheter ACU 1060.1, labeled sterile if unopened. || The Jet Ventilation Catheter allows a safe and atraumatic transtracheal access for oxygenation/ventilation.
  • Manufacturer
    Instrumentation Industries Inc

Manufacturer

Instrumentation Industries Inc