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-0423-05
  • 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=36156
  • 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: Last 6 digits  01092304, 01092404, 01092804, 01092904, 01093004, 01100504, 01100604, 01100704 01100804, 01101104, 01101204, 01101404 01101504, 02101804, 01101904, 01102004 01102104, 01102204, 01102504, 05102504 01102604, 01102804, 01102904, 01110104 01110204, 01110504, 09111004, 01111104 05111204, 09111604, 01111704, 01111904 01112204, 09112404, 09113004, 09120204
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Forign: Canada, Greece, Japna, Israel, Saudi Arabia,
  • Product Description
    Bio Med Devices Patient Breathing Circuit || Catalog Number: 80011 || Labeled in part: '':PATIENT BREATHING CIRCUIT || =-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-= CONTENTS: 1-PATIENT HOSE 22mmIDx42'' 1-PRESSURE GAGE LINE 3/16''IDx54'' || 1-PATIENT HOSE 22mmIDx24'' 3-ADAPTERS 22mm x 22mm || 1-PATIENT HOSE 22mmIDx6'' 1-ADULT PRESSURE TEE || 1-EXHALATION VALVE w/HOLDING ARM& || 1-TEMPERATURE ADAPTER 22mmID x 22mm || COLLECTION HEAD 2-CUFF 1/4''ID x 5/4'' || 1-EXHALATION VALVE LINE 1/8''IDx52''
  • 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