Events

Recall of Infant Ventilators with Electronic Manometer. || Models IV-100B; IV-200 and IV-200 SAVI.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sechrist Industries 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
    29228
  • Event Risk Class
    Class 2
  • Event Number
    Z-1032-04
  • Event Initiated Date
    2004-05-20
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-03-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33362
  • 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
    Electronic manometer malfunctions. manometer may be illegible. the alarm for power failure may function only briefly, or not at all.
  • Action
    Recall notification contains a test method to be used to identify defective units. Return notification that ventilator is defective will result in replacement of the electronic manometer.

Device

Infant Ventilators with Electronic Manometer. || Models IV-100B; IV-200 and IV-200 SAVI.
  • Model / Serial
    Restricted to those ventilators with production serial numbers beginning with a ''00'' prefix.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and to Malaysia, Japan, Kuwait, Sri Lanka, South Africa, Guatemala, Mexico, Morocco, Indonesia, Korea, Ecuador, Colombia, Portugal, Oman, Switzerland, Spain, Zimbabwe, Belgium, Brazil, Thailand, Argentina, Costa Rica, Taiwan, ROC, India, Russia, Saudi Arabia, Pakistan, Caribbean, Venezuela.
  • Product Description
    Infant Ventilators with Electronic Manometer. || Models IV-100B; IV-200 and IV-200 SAVI.
  • Manufacturer
    Sechrist Industries Inc

Manufacturer

Sechrist Industries Inc
  • Manufacturer Address
    Sechrist Industries Inc, 4225 E La Palma Ave, Anaheim CA 92807-1815
  • Manufacturer Parent Company (2017)
    Sechrist Industries Inc.
  • Source
    USFDA