Events

Recall of Portex Uncuffed Oral/Nasal Tracheal Tubes, Siliconised || 3mm x 17cm || Reference Number: 100/111/030

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Portex 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
    26394
  • Event Risk Class
    Class 2
  • Event Number
    Z-0992-03
  • Event Initiated Date
    2003-05-16
  • Event Date Posted
    2003-07-19
  • 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=27624
  • 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
  • Reason
    Tracheal tubes may be non-sterile.
  • Action
    Portex Inc. Keene,NH initiated the recall by telephone to direct accounts on 5/16/03. A follow-up Recall Notification letter was issued by Federal Express on May 17, 2003. Dealers were asked to provide a consignee list or contact their accounts directly. Unused product is requested to be returned from the distributors and medical facilities.

Device

Portex Uncuffed Oral/Nasal Tracheal Tubes, Siliconised || 3mm x 17cm || Reference Number: 100/111...
  • Model / Serial
    Lot Number: 161633
  • Distribution
    Nationwide
  • Product Description
    Portex Uncuffed Oral/Nasal Tracheal Tubes, Siliconised || 3mm x 17cm || Reference Number: 100/111/030
  • Manufacturer
    Portex Ltd.

Manufacturer

Portex Ltd.
  • Manufacturer Address
    Portex Ltd., Reachfields, Boundry Road, Hythe, Kent United Kingdom
  • Source
    USFDA