Recall of Device Recall Nova Biomedical

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Nova Biomedical 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
    28725
  • Event Risk Class
    Class 2
  • Event Number
    Z-0830-04
  • Event Initiated Date
    2004-03-30
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2004-06-17
  • Event Source
    USFDA
  • Event Source URL
  • 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
    Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph - Product Code CHL
  • Reason
    Incorrectly assembled pumps may result in inconsistent compression of the tubing causing erratic results or calibration problems.
  • Action
    Nova Biomedical notified users by telephone on 3/31/04 and conducted follow-up by letter either by email or fax. On-site visit will be scheduled to replace the pump assembly.

Device

  • Model / Serial
    Devices shipped between March 30-31, 2004
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA, IL, LA, MA ,NJ, NY, OH, PA, TX International: Italy ,England, Japan,Turkey., U.A.E., Greece, Thailand, Switzerland, Finland, Saudi Arabia, Italy, Mexico, Trinidad, Ireland, France, Cyprus, Czech Republic, ,Germany
  • Product Description
    ABG Replacement Pump Assembly || Catalog Number: 37092
  • Manufacturer

Manufacturer

  • Manufacturer Address
    Nova Biomedical Corporation, 200 Prospect St, Waltham MA 02453-3457
  • Manufacturer Parent Company (2017)
  • Source
    USFDA