Events

Recall of Device Recall Medline Extended PTFE Coated Blade electrosurgical electrodes

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Unimed Surgical Products, 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
    53498
  • Event Risk Class
    Class 2
  • Event Number
    Z-0069-2010
  • Event Initiated Date
    2009-08-28
  • Event Date Posted
    2009-10-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-05-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85641
  • 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 & accessories - Product Code GEI
  • Reason
    Unimed surgical products, inc., largo, fl initiated a voluntary recall of the extended ptfe coated blade electrosurgical electrodes, product number es0014, due to concerns regarding product sterility for lot #042209-03.
  • Action
    Unimed Surgical Products, Inc. issued a Medical Device Removal letter dated August 28, 2009. The customer, Medline Industries, Inc., was instructed to quarantine any undistributed product and to notify its customers of the recall. For further information, contact Unimed Surgical Products, Inc. at 1-727-546-1900 or 1-800-886-1225.

Device

Device Recall Medline Extended PTFE Coated Blade electrosurgical electrodes
  • Model / Serial
    Product Order No. ES0014, Lot Number: 042209-03.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- MI
  • Product Description
    Extended PTFE Coated Blade electrosurgical electrodes, 6.5" (16.51CM) Length, 12 each & 20 each per box, Labeled MEDLINE brand. || Manufactured for Medline Industries, Inc. Mundelein, IL 60060 USA Made in USA MEDLINE in a registered trademark of Medline Industries, Inc. 1-800-MEDLINE.
  • Manufacturer
    Unimed Surgical Products, Inc.

Manufacturer

Unimed Surgical Products, Inc.
  • Manufacturer Address
    Unimed Surgical Products, Inc., 10401 Belcher Rd South, Largo FL 33777-1415
  • Manufacturer Parent Company (2017)
    Unimed Surgical Products Inc
  • Source
    USFDA