Events

Recall of Device Recall Silicone CTS Tracheostomy Tube

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Arcadia Medical Corporation.

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
    58828
  • Event Risk Class
    Class 2
  • Event Number
    Z-2657-2011
  • Event Initiated Date
    2011-05-08
  • Event Date Posted
    2011-06-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-08-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100382
  • 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
    Tracheostomy tube (w/wo connector) - Product Code BTO
  • Reason
    The product does not contain a punched hole above the cuff access port (a lumen that enables suctioning of secretions proximal to the inflated cuff) as intended by the devices design. this eliminates the user's ability to suction secretions through this suction port, necessitating that the user revert to standard of care methods for suctioning secretions from around the cuffed trach tube shaft.
  • Action
    Arcadia Medical Corporation sent a "MEDICAL DEVICE RECALL" letter on May 9, 2011 and email on May 8, 2011 to all affected costumers. The letter included; description of the product name, afffected lot numbers, description of the problem, instructions to discontinue use of the recalled devices and to return them to Arcadia Medical for replacement . The letter instructed the customers to email Arcadia Medical with the number of devices in their inventory. For additional information contact Arcadia Medical Corporation at 219-779-9431.

Device

Device Recall Silicone CTS Tracheostomy Tube
  • Model / Serial
    Lots 00911114 Catalog # 180-060, and Lot 00911116 Catalog # 180-080
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --USA including the state of Ohio, and the countries of Denmark, Italy, Germany, Turkey, Slovakia, Isreal, France, Sweden, and Romania
  • Product Description
    Silicone CTS (Close to Shaft) Cuff Adjustable Neck Flange Tracheostomy Tube (Wire Reinforced), Arcadia Medical Silicone Air Cuff Adjustable Tracheostomy Tube, Sterile, Latex-Free, || Provides direct tracheal access for airway management || Arcadia Medical Corporation || 1450 East American Lane, Schaumburg, IL 60173 USA || Arcadia Medical Corporation Tortola, British Virgin Islands || www.arcadiamedical.com, Made in USA
  • Manufacturer
    Arcadia Medical Corporation

Manufacturer

Arcadia Medical Corporation
  • Manufacturer Address
    Arcadia Medical Corporation, 1140 Millennium Dr, Crown Point IN 46307-7533
  • Source
    USFDA