Events

Recall of Device Recall Puritan Bennett KnightStar Ventilator

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

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
    36306
  • Event Risk Class
    Class 2
  • Event Number
    Z-0444-2007
  • Event Initiated Date
    2006-08-31
  • Event Date Posted
    2007-01-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-03-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48388
  • 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, Minimum Support, Facility - Product Code MNT
  • Reason
    Directions for use-puritan bennett has determined that a service interval should be defined for the device. the firm has also determined that an exhalation filter should be employed when the device is in use.
  • Action
    Domestic customers of record will be advised of this matter by letter sent via Certified US Mail, Return Receipt. The letter will provide recipients with simple instructions on how they may return their units for service, and provides scheduled dates for service for each of their devices, based upon Nellcor Puritan Bennett shipment records.

Device

Device Recall Puritan Bennett KnightStar Ventilator
  • Model / Serial
    All units are subject to this notice (all serial numbers).
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution ---- including USA and countries of Argentina, Australia, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Mexico, Netherlands, Norway, Poland, Portugal, Peru, Puerto Rico, Russia, Saudi Arabia, Scotland, Serbia & Montenegro, Singapore, Slovak Republic, South Africa, Spain, Switzerland, Syria, Turkey, United Arab Emirates, United Kingdom and Venezuela.
  • Product Description
    Puritan Bennett KnightStar 330 Bi-Level Ventilator, Catalogue Numbers: Y-KS330-NA, Y-KS330-SD, DSY-KS330-NA, DSY-K5330-SD, DLY-KS330-NA & DLY-KS330-SD
  • Manufacturer
    Puritan Bennett Corporation

Manufacturer

Puritan Bennett Corporation
  • Manufacturer Address
    Puritan Bennett Corporation, 5931 Priestly Dr Ste 100, Carlsbad CA 92008-8813
  • Source
    USFDA