Events

Recall of Device Recall IMA/ENT Blade Electrode

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Telefelx 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
    56379
  • Event Risk Class
    Class 2
  • Event Number
    Z-2584-2010
  • Event Initiated Date
    2010-07-30
  • Event Date Posted
    2010-09-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-04-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93337
  • 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
    Electrosurgical, cutting; coagulation and accessories - Product Code GEI
  • Reason
    Complaints were received regarding peeling and melting of the insulation of the cautery tip of the ima/ent blade electrodes.
  • Action
    Teleflex Medical sent an "Urgent Medical Device Recall" letter dated July 30, 2010, to all customers. The letter described the product, problem and actions to be taken by customers. The customers were instructed to immediately discontinue use, quarantine any affected products and return all of the affected product to Teleflex Medical; forward the letter to their customers to retrieve product from those locations and complete and return the Recall Acknowledgement Form via fax at 1-866-804-9881. A second mailing to non-responding customers on the consignee list will be mailed approximately four to six seeks after the first mailing. A third mailing to non-responding customers on the consignee list will be made approximately four to six weeks after the second mailing or as an alternative, they may be contacted by phone, e-mail, or fax. Note: A record of these contacts will be maintained. Affected products received by Teleflex Medical will be destroyed upon receipt. Records will be maintained accordingly. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.

Device

Device Recall IMA/ENT Blade Electrode
  • Model / Serial
    Catalog number: 809335, Lot numbers: 2218273, 2227760, T1213320, T1214910, 01K0700276, 01L0700066, 01M0700224, 01E0800244, 0G0800102, 01G0800132, 01J0800040, 01J0800288, 01J0800376, 01K0800195, 01K0800281, 01L0800228 and 01D0900449.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA and countries of Canada, Australia and Singapore.
  • Product Description
    WECK IMA/ENT Blade Electrode ¿ (1.9 cm), REF 809335, Rx Only Sterile, Teleflex Medical, RTP, NC || The blade electrode is used in a wide variety of surgical procedures. The most common uses for electrodes with extended insulation is in cardiac bypass surgery (used in the take-down of the internal mammary artery or IMA) and ear, nose and throat surgery. They are sold non-sterile and are used one time and then disposed.
  • Manufacturer
    Telefelx Medical

Manufacturer

Telefelx Medical
  • Manufacturer Address
    Telefelx Medical, 2917 Weck Drive, Durham NC 27709
  • Manufacturer Parent Company (2017)
    Teleflex Incorporated
  • Source
    USFDA