Events

Recall of Bio Med Devices

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Biomed Devices.

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
    57051
  • Event Risk Class
    Class 2
  • Event Number
    Z-0972-2011
  • Event Initiated Date
    2010-10-19
  • Event Date Posted
    2011-01-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-10-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95250
  • 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
    Breathing circuit may disconnect between the adapter adjacent tubing cuff.
  • Action
    The firm,Bio Med Devices, sent a "URGENT MEDICAL DEVICE RECALL" letter dated October 18, 2010 via fax to the customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to immediately examine their stock for the affected lots, if found, discontinue distributing and using the product and promptly return via UPS #025106 to Bio-Med Devices 61 Soundview Rd, Guilford, CT 06437, Attention: 4040LC Recall Return. The customers were also instructed to immediately contact their accounts, if the product was further distributed , advise them of the recall situation and have their outstanding product returned, and to complete and return the RETURN FAX-IMMEDIATE RESPONSE REQUIRED form via fax to 203-458-0440. Note: Bio-Med informed the customers that they will credit the return product; however, they only plan to replace the product in an emergency situation, because they have very few of the 3/8" x 15mm adapters left and are looking to discontinue the 4040LC due to the discontinuance of this product by the manufacturer. If you have any questions, please contact (203) 458-0202 x 217.

Device

Bio Med Devices
  • Model / Serial
    Lot Numbers:  09072210 09081310, 09082510, 05091510
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: OH, WI.
  • Product Description
    Bio Med Devices Disposable Pediatric Breathing Circuit, One Set || Catalog Number: 4040LC || 5 foot /15mm corrugated EVA hose || Intended use: Breathing circuit is a pediatric disposable tubing assembly for use with Lifecare ventilators
  • Manufacturer
    Biomed Devices

Manufacturer

Biomed Devices
  • Manufacturer Address
    Biomed Devices, 61 Soundview Rd, Guilford CT 06437-2937
  • Source
    USFDA