Events

Recall of Puritan Bennett 840 Series Ventilator Power Supply

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

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
    31936
  • Event Risk Class
    Class 2
  • Event Number
    Z-1085-05
  • Event Initiated Date
    2005-04-20
  • Event Date Posted
    2005-08-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-01-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38778
  • 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
    Ventilator, Continuous, Facility Use - Product Code CBK
  • Reason
    Manufacturing defect at contract manufacturer, employee error, poor training, improper inspection.
  • Action
    Recall is by letter sent Fedex 4/20/05. After two weeks nonrespondants will be telephoned. Foreign customers will be handled by firm''s local offices similarly.

Device

Puritan Bennett 840 Series Ventilator Power Supply
  • Model / Serial
    All codes
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA, Canada and Europe.
  • Product Description
    Puritan Bennett 840 Series Ventilator Power Supply || Model/Catalog Numbers: 4-076314-00; 4-076314-SP
  • Manufacturer
    Puritan Bennett

Manufacturer

Puritan Bennett
  • Manufacturer Address
    Puritan Bennett, 4280 Hacienda Dr, Pleasanton CA 94588-2719
  • Source
    USFDA