Events

Recall of Tracheostomy tubes

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
    61663
  • Event Risk Class
    Class 2
  • Event Number
    Z-1628-2012
  • Event Initiated Date
    2012-04-18
  • Event Date Posted
    2012-05-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108664
  • 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
    A defect in 3 tracheostomy tubes. the defect observed was a separation in the bond between the proximal junction of the neck flange and the cannula.
  • Action
    Arcadia notified the 3 consignees with a MEDICAL DEVICE VOLUNTARY RECALL notification dated 4/18/12. The notification identified the affected product, along with the reason for the recall. Consignees were instructed to cease distribution/use of any unopened product that they have remaining and return to firm following the steps provided. Arcadia will replace the product at no charge to the customer. Consignees were to confirm receipt of the recall notification by emailing Trena Depel, trena@arcadiamedical.com. Phone: 925-918-0595 Fax: (415) 762-5489

Device

Tracheostomy tubes
  • Model / Serial
    Lot numbers: 01103307 (50 units) and 01107055 (73 units)
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US, including Mariemount, OH and countries of UK and France.
  • Product Description
    Silicone Cuffed Wire Reinforced Extended Connect Pediatric Perfect Fit Neck Flange Tracheostomy Tube, Size 4.0 mm I.D. Catalog Number 353-040. || Intended for use in providing direct tracheal access for airway management.
  • Manufacturer
    Arcadia Medical Corporation

Manufacturer

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