Events

Recall of Nellcor Puritan Bennett

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Nellcor 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
    31271
  • Event Risk Class
    Class 2
  • Event Number
    Z-0663-05
  • Event Initiated Date
    2004-10-18
  • Event Date Posted
    2005-03-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-05-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37554
  • 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
    Oximeter - Product Code DQA
  • Reason
    The internal speaker components are failing and do not produce an audio alarm in the event of patient emergency.
  • Action
    Customers of record were notified of the advisory by letter sent via US Mail on October 18, 2004, via certified mail. A second letter was sent on December 9, 2004, advising customers that upgrades would be available. Upgrades would be available via returns to the firm''s service center, upgrade kits and speaker replacements via self-installation, and a third party service provider.

Device

Nellcor Puritan Bennett
  • Model / Serial
    All units with serial numbers beginning with G01844386.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    There are 2,950 Direct US and US territory Customers. Product shave also been distributed to Canada, Europe, Japan, Latin America and Australia.
  • Product Description
    Nellcor Puritan Bennett brand Pulse Oximeter, Model NPB295, || Made in Ireland; Distributed by Nellcor Puritan Bennett, Inc. Pleasanton, CA 94588 U.S.A.
  • Manufacturer
    Nellcor Puritan Bennett

Manufacturer

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