Events

Recall of Portex Per-Fit Percutaneous Dilational Tracheostomy Kit , ID 8.0mm || Product Number: 538080E

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
    32079
  • Event Risk Class
    Class 2
  • Event Number
    Z-0871-05
  • Event Initiated Date
    2005-05-16
  • Event Date Posted
    2005-06-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=39092
  • 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
    Guiding catheter may have thinner and weaker sidewalls than designed, and may break.
  • Action
    Smith Medical ASD initiated recall by letter on/about about May 16, 2005.

Device

Portex Per-Fit Percutaneous Dilational Tracheostomy Kit , ID 8.0mm || Product Number: 538080E
  • Model / Serial
    Lot Numbers: K510892, K565595
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Natiowide Foreign: Canada, Mexico and East Timor.
  • Product Description
    Portex Per-Fit Percutaneous Dilational Tracheostomy Kit , ID 8.0mm || Product Number: 538080E
  • Manufacturer
    Smiths Medical ASD, Inc.

Manufacturer

Smiths Medical ASD, Inc.
  • Manufacturer Address
    Smiths Medical ASD, Inc., 10 Bowman Dr, Keene NH 03431-5043
  • Manufacturer Parent Company (2017)
    Smiths Group Plc
  • Source
    USFDA