Events

Recall of Device Recall 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
    28183
  • Event Risk Class
    Class 3
  • Event Number
    Z-0572-04
  • Event Initiated Date
    2004-01-26
  • Event Date Posted
    2004-07-20
  • 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=31341
  • 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
    Stylet, Tracheal Tube - Product Code BSR
  • Reason
    Tracheal tube guide mislabeled as a 15 fr instead of a 10 fr.
  • Action
    Smiths Medical notified consignees by letter dated 1/26/04 by FedEx. Customers are requested to inspect their inventory for the size. Incorrectly labeled product is to be returned for credit or replacement. Customers and dealers are directed to fax back the attached Reply Letter.

Device

Device Recall Portex
  • Model / Serial
    Lot Number: K221961
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    CA, CO, FL, GA, IN, MA, MD, MI. NH, NC, NY, TX, WA
  • Product Description
    Portex Tracheal Tube Guide 15 Fr, non-sterile || Catalog Number: 153013
  • Manufacturer
    Smiths Medical ASD, Inc

Manufacturer

Smiths Medical ASD, Inc
  • Manufacturer Address
    Smiths Medical ASD, Inc, 10 Bowman Dr, Keene NH 03431-5043
  • Source
    USFDA