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
    30580
  • Event Risk Class
    Class 1
  • Event Number
    Z-0428-05
  • Event Initiated Date
    2004-12-06
  • Event Date Posted
    2005-01-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-11-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36173
  • 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
    Adapters may be occluded potentially preventing inhalation.
  • Action
    Bio-Med Devices issued recall notifcation by fax on 12/7/04. Accounts are requested to discontine use and return product. A Press Release issued to AP 12/8/04

Device

Device Recall BioMed Devices
  • Model / Serial
    Lot Numbers: 05092204, 05101104, 05101304, 05101404 05102004, 05102604, 05102804, 05110204 05110304, 05110904, 05111804, 05112404 05120104
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Forign: Canada, Greece, Japna, Israel, Saudi Arabia,
  • Product Description
    Pneumotach, Disposable (B) || Catalog Number: 4408 || Labeled in part: || SINGLE USE CATALOG NO.4408 || PNEUMOTACH, DISPOSABLE (B) || =-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-= || CONTENTS: || 1- PNEUMOTACH HEAD ASSEMBLY 1- PARATUBE 60'' || 2- TUBING FITTINGS || 1- 22x22mm ADAPTER
  • Manufacturer
    Bio-Med Devices, Inc.

Manufacturer

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