Events

Recall of Device Recall Green Spec Fiberoptic Laryngoscope Handle Stubby/Short

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

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
    35669
  • Event Risk Class
    Class 2
  • Event Number
    Z-1225-06
  • Event Initiated Date
    2006-06-15
  • Event Date Posted
    2006-07-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-08-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46584
  • 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 Handle - Product Code CCW
  • Reason
    Teleflex medical has identified that the product may malfunction, causing the handle to heat up. there is a potential for the heated handle to burn the user.
  • Action
    Teleflex Medical sent Urgent Medical Device Recall letters dated 6/15/06 to the direct accounts, informing them of the potential for the handle to heat up, and requesting that they cease use of the affected units and return them to Teleflex Medical for replacement. The accounts were instructed to complete and return by fax the enclosed Acknowledgement & Stock Status Form, indicating the number of units being returned for replacement. Any questions were directed to Linda Todd at 1-800-334-9751, ext. 4951.

Device

Device Recall Green Spec Fiberoptic Laryngoscope Handle Stubby/Short
  • Model / Serial
    catalog number 004413300, any lot number greater than and including 050901. Please note: the lot number is located at the top of the handle, where the laryngoscope hinge attaches to the blade.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada, Colombia, Costa Rica and Chile.
  • Product Description
    Green Spec Fiberoptic Laryngoscope Handle - Stubby/Short; a battery operated fiberoptic laryngoscope handle for use with green coded fiberoptic systems and single use laryngoscope blades; Teleflex Medical, Bannockburn, IL 60015; catalog number 004413300
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical
  • Manufacturer Address
    Teleflex Medical, 2345 Waukegan Rd Ste 120, Bannockburn IL 60015-1580
  • Source
    USFDA