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 International Ltd.

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
    32297
  • Event Risk Class
    Class 2
  • Event Number
    Z-0961-05
  • Event Initiated Date
    2005-06-07
  • Event Date Posted
    2005-07-07
  • 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=39537
  • 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
    Filter, Bacterial, Breathing-Circuit - Product Code CAH
  • Reason
    Mislabeled: the package contains a heat and moisture (hme) filter instead of a hepa filter stated on the product label.
  • Action
    Smiths Medical notified 8 accounts by letter dated June 3, 2005. Distributors are requested to contact accounts end-users (hospitals) . Users are requested to return inventory.

Device

Device Recall Portex

Manufacturer

Smiths Medical International Ltd
  • Manufacturer Address
    Smiths Medical International Ltd, Reachfields, Boundry Road, Hythe United Kingdom
  • Source
    USFDA