Events

Recall of Device Recall BOMImed Reusable Integrated Fiber Optic Laryngoscope Blades

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bomimed 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
    61464
  • Event Risk Class
    Class 2
  • Event Number
    Z-1488-2012
  • Event Initiated Date
    2010-12-08
  • Event Date Posted
    2012-05-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108164
  • 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, nasopharyngoscope - Product Code EQN
  • Reason
    On 9/1/2010 bomimed, inc. winnipeg, mb, canada initiated a recall of their bomimed integrated reusable laryngoscope blades (macintosh & miller styles - all sizes), model #ol-32d0 to ol-32d4 & ol-32e00, ol-32e0, ol-32e1, ol-32e2, ol-32e3, ol-32e4.
  • Action
    BOMImed sent a "Medical Device Safety Alert & Correction Action" letter by Fax and Mail on 11/25/2010 to the consignee. The product issue was described and recommended actions to mitigate risk were provided. Contact number is 1-800-667-6276 ext. 234.

Device

Device Recall BOMImed Reusable Integrated Fiber Optic Laryngoscope Blades
  • Model / Serial
    Lot Numbers 0310, 0510, 2710, 3210, 4010 & 4510
  • Product Classification
    Ear, Nose, and Throat Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the state of California.
  • Product Description
    BOMImed Reusable Integrated Fiber Optic Laryngoscope Blades, MacIntosh and Miller styles - all sizes. Instrument is used to aid with intubation.
  • Manufacturer
    Bomimed Inc

Manufacturer

Bomimed Inc
  • Manufacturer Address
    Bomimed Inc, 96 Terracon Pl, Winnipeg Canada Manitoba
  • Manufacturer Parent Company (2017)
    Bomimed Inc
  • Source
    USFDA