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-0427-05
  • 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=36167
  • 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: 05092404, 01100404, 05100604, 05100704 05100804, 05101304, 05101404, 05101504 05101904, 05102204, 05102804, 05110404 02110504, 05110804, 01110904, 05111204 05111504, 01111804, 05112204, 09120104
  • 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: 8002A-9 || Labeled in part: || ONE SET - SINGLE USE CATALOG NO. 8002A-9 || PATIENT BREATHING CIRCUIT || =-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-= || CONTENTS: || 1-PATIENT HOSE 22mmIDx60'' || 1-EXHALATION VALVE LINE 1/8''IDx108'' || 1-PATIENT HOSE 22mmIDx36'' || 1-PATIENT HOSE 22mmIDx6'' || 1-PRESSURE GAGE LINE || 1-EXHALATION VALVE w/HOLDING || ARM&COLLECTION; HEAD || 102'' w/CUFF 1/4''ID || 1-ADULT PRESSURE TEE w/CUFF || 3-ADAPTERS 22mmx22mm
  • 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