Events

Recall of Device Recall Portex/Sims Portex

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smiths Medical ASD, 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
    29136
  • Event Risk Class
    Class 2
  • Event Number
    Z-1016-04
  • Event Initiated Date
    2004-05-19
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-05-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33190
  • 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 And Tube Cuff - Product Code JOH
  • Reason
    Incompatible products may cause potential trachea trauma.
  • Action
    Smiths Medical ASD notified the consignees by letter, dated 5/21/04. All responses to the notification are to be completed by fax and directed to Smiths Medical Regulatory Affairs Departement. The recalled products are to be returned and scrapped by Smiths Medical.

Device

Device Recall Portex/Sims Portex
  • Model / Serial
    All Lot Numbers
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Portex Inner Cannula for Tracheostomy Tube, 8.0 mm, REF Code 566080
  • Manufacturer
    Smiths Medical ASD, Inc

Manufacturer

Smiths Medical ASD, Inc
  • Manufacturer Address
    Smiths Medical ASD, Inc, Anesthesia and Safety Devices Division, 10 Bowman Drive, Keene NH 03431-0724
  • Source
    USFDA