Events

Recall of Device Recall SIMS/Portex

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Portex 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
    26621
  • Event Risk Class
    Class 3
  • Event Number
    Z-1039-03
  • Event Initiated Date
    2003-06-18
  • Event Date Posted
    2003-07-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-03-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28013
  • 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
    Mislabeled:tracheostomy tube was not fenestrated as specified on the label.
  • Action
    Portex notified four user facilities by telephone on June 18th and 19th, 2003 . The consignees were instructed to check their inventory for any affected product and to call to make arrangements for the return and credit of the affected product. If the product was in use, they were instructed to remove the fenestrated label on the inflation line and to inform the patient and healthcare provider of the discrepancy.

Device

Device Recall SIMS/Portex
  • Model / Serial
    Lot Number: 905486 EXP: 2004-05
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA, GA, KA, MO
  • Product Description
    Lo-Profile Fenestrated Tracheostomy Tube, Cuffed and Fenestrated Tube I.D. 9.0mm || Catalog Number: 593090
  • Manufacturer
    Portex Inc.

Manufacturer

Portex Inc.
  • Manufacturer Address
    Portex Inc., 10 Bowman Drive, Keene NH 03431
  • Source
    USFDA