Events

Recall of Device Recall HUDSON RCI

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Teleflex Creek Dr.

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
    45426
  • Event Risk Class
    Class 2
  • Event Number
    Z-0211-2008
  • Event Initiated Date
    2007-08-22
  • Event Date Posted
    2007-12-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65454
  • 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
    Nebulizer - Product Code CAF
  • Reason
    Decreased in flow output; through the nebulizer -(when used at higher oxygen concentration settings, this decrease in flow, may lower the oxygen concentration inspired by the patient).
  • Action
    Customers were notified by an Urgent Medical Device Recall letter on/about 08/22/2007. They were instructed to return the affected products to Teleflex Medical or acknowledge that the products no longer exist. In addition, each were instructed to forward the letter if they have further distributed into institutional settings or to homecare patients and retrieve relevant product from those locations. This recall is to the consumer/user level via sub-recall from distributors or direct accounts as per the Recalling firm.

Device

Device Recall HUDSON RCI
  • Model / Serial
    Product Code/Catalog Number: 1770; Lot Numbers: 49069, 50069, 51069, 52069, 53069, 01079, 02079, 03079, 04079, 06079, 12079, 1279R, 13079, 15079, 16079, 17079, 17079R, 18079, 19079, 19079R and 20079. PRODUCT CODE/CATALOG NUMBER: 41770, Lot Numbers: 50069, 52069, 01079, 06079, 16079, 17079, 17079R, and 18079.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide: USA, Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, France, Germany, Guatemala, India, Mexico, Panama, Peru, Philippines, South Korea, Thailand, United Arab Emirates, and The United Kingdom.
  • Product Description
    HUDSON RCI¿, Variable Concentration, Large Volume Nebulizer, Catalog Number (REF) 1770 and 41770, Rx Only, Teleflex Medical, Research Triangle Park, NC 27709.
  • Manufacturer
    Teleflex Creek Dr

Manufacturer

Teleflex Creek Dr
  • Manufacturer Address
    Teleflex Creek Dr, 4024 Stirrup Creek Dr, Durham NC 27703-9000
  • Source
    USFDA