Events

Recall of Device Recall BOMImed Disposable Fiber Optic Medium Laryngoscope Handle

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

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
    77958
  • Event Risk Class
    Class 2
  • Event Number
    Z-3238-2017
  • Event Initiated Date
    2017-07-13
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158329
  • 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
    Laryngoscope, rigid - Product Code CCW
  • Reason
    Potential for intermittent lighting (flickering) during use.
  • Action
    A letter was sent to all the consignees via mail dated July 13, 2017 informing of the recall due to Length variation of the battery contact inside the handle due to manufacturing/assembly variation may potentially cause an intermittent electrical connection resulting in flickering light. Complete the bottom section and return by email to regulatory@bomimed.com to confirm this notice has been received and understood. Check functionality of the light for each handle by engaging a blade and applying pressure to simulate use. Complete this task prior to use. Contact BOMImed for replacements if intermittent lighting is present. Replacement product orders will be organized in a manner to assist in covering all affected customers needs. Contac: Trina Friesen Quality Assurance & Regulatory Manager Tel: 800-667-6276 ext.234 Fax: 877-435-6984 regulatory@bomimed.com

Device

Device Recall BOMImed Disposable Fiber Optic Medium Laryngoscope Handle
  • Model / Serial
    Part number: OL-334L6 Lot#: 2216, 3016, 4016 and 4816
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    IL. PA. and WA CANADA
  • Product Description
    BOMImed Disposable Fiber Optic Medium Laryngoscope Handle. Each handle is packaged in an individual peel pouch, 20 handles per box. || The rigid laryngoscope handle is a device used along with a blade to examine and visualize a patient's airway and aid placement of a tracheal tube.
  • Manufacturer
    Bomimed

Manufacturer

Bomimed
  • Manufacturer Address
    Bomimed, 1-100 Irene St, Winnipeg Canada
  • Manufacturer Parent Company (2017)
    Bomimed Inc
  • Source
    USFDA