Events

Recall of Device Recall CareFusion Vital Signs Introduction Pack

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Vital Signs Colorado 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
    70753
  • Event Risk Class
    Class 2
  • Event Number
    Z-1557-2015
  • Event Initiated Date
    2015-03-13
  • Event Date Posted
    2015-04-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-10-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134609
  • 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
    Vital signs colorado (dba carefusion) is recalling vital signs lightwand stylet catalog numbers 3910 and 3960 due to a potential patient safety risk involving a breach in the sterile packaging that may not be recognized prior to use.
  • Action
    Customers were notified on 3/13/15 via letter to perform an inventory, complete and return the Recall Response Form within 15 days, and to destroy the product on site (do not return to CareFusion).

Device

Device Recall CareFusion Vital Signs Introduction Pack
  • Model / Serial
    Catalog Number 3960
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution. US Nationwide, Australia, Canada, Chile, Colombia, Dominican Republic, Ecuador, Egypt, Germany, Guatemala, Hong Kong, India, Israel, Italy, Japan, South Korea, Lebanon, Mexico, Netherlands, New Zealand, Panama, Peru, Poland, Russia, Slovenia, Turkey, United Kingdom, and Qatar.
  • Product Description
    Introduction Pack. A device inserted into an endotracheal tube to aid in the intubation procedure.
  • Manufacturer
    Vital Signs Colorado Inc.

Manufacturer

Vital Signs Colorado Inc.
  • Manufacturer Address
    Vital Signs Colorado Inc., 11039 East Lansing Circle, Englewood CO 80112-5909
  • Source
    USFDA