Events

Recall of LTV Series Ventilators, Models 1000, 950, 900, and 800.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cardinal Health 203, 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
    29978
  • Event Risk Class
    Class 1
  • Event Number
    Z-1485-04
  • Event Initiated Date
    2004-09-08
  • Event Date Posted
    2004-09-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-05-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34902
  • 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
    Continuous Ventilator - Product Code CBK
  • Reason
    Ventilators have not consistently switched to internal battery operation when the external dc power source has become inadequate to supply stable power. this situation results in loss of ventilation to the patient.
  • Action
    A letter titled "Important Safety Information", dated September 7, 2004, was issued to all affected customers alerting them to the possibility of ventilator failure and providing instructions for recognizing and responding to the situation.

Device

LTV Series Ventilators, Models 1000, 950, 900, and 800.
  • Model / Serial
    Recalled ventilators were manufactured prior to September 2003. Models LTV 1000, 950, 900, and 900 Model contain serial numbers less than A006500, C07000, B03500, and D01400, respectively.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and worldwide
  • Product Description
    The LTV Series ventilators provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. This is a prescription medical device intended for use by personnel under the direction of a physician. The ventilator is suitable for use in institutional, home and transport settings.
  • Manufacturer
    Cardinal Health 203, Inc

Manufacturer

Cardinal Health 203, Inc
  • Manufacturer Address
    Cardinal Health 203, Inc, 17400 Medina Rd Ste 100, Minneapolis MN 55447-1341
  • Manufacturer Parent Company (2017)
    Cardinal Health
  • Source
    USFDA