Events

Recall of Device Recall BioMed Devices

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bio-Med Devices, 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
    27937
  • Event Risk Class
    Class 2
  • Event Number
    Z-0300-04
  • Event Initiated Date
    2003-11-07
  • Event Date Posted
    2004-01-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30770
  • 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, Minimal Ventilatory Support, Facility Use - Product Code MNT
  • Reason
    Two way relief valve may fail to activate at the low negative pressure of -3cm h2o.
  • Action
    Bio Med Devices notified accounts by telephone on 11/7/03, to return the device for replacement and correction.

Device

Device Recall BioMed Devices
  • Model / Serial
    S/N: 3023031, 3025031, 0957951
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    ID, PA, TX
  • Product Description
    MVP-10 Pediatric/ Neonatal Volume Ventilator
  • Manufacturer
    Bio-Med Devices, Inc.

Manufacturer

Bio-Med Devices, Inc.
  • Manufacturer Address
    Bio-Med Devices, Inc., 1445 Boston Post Rd, Guilford CT 06437-4338
  • Source
    USFDA