Events

Recall of Device Recall Puritan Bennett Ventilator System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Nellcor Puritan Bennett 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
    30785
  • Event Risk Class
    Class 2
  • Event Number
    Z-0445-05
  • Event Initiated Date
    2004-12-17
  • Event Date Posted
    2005-01-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-01-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36598
  • 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
    Capacitor weakness in backup alarm system might fail causing lack of backup alarm to function in the event of total power loss.
  • Action
    Customers of record will be notified by letter sent FEDEX, a simple test instruction will be included to use to test the performance of the backup alarm.

Device

Device Recall Puritan Bennett Ventilator System
  • Model / Serial
    All units ever manufactured. The product may be identified and tracked through serial numbers. This is a tracked device.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide.
  • Product Description
    Model 740 and 760 series Ventilators.
  • Manufacturer
    Nellcor Puritan Bennett Inc

Manufacturer

Nellcor Puritan Bennett Inc
  • Manufacturer Address
    Nellcor Puritan Bennett Inc, 2200 Faraday Ave, Carlsbad CA 92008-7208
  • Source
    USFDA