Events

Recall of Device Recall Mediline Industries, Inc.

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
    61982
  • Event Risk Class
    Class 2
  • Event Number
    Z-2289-2012
  • Event Initiated Date
    2010-06-16
  • Event Date Posted
    2012-08-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111222
  • 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
    On 6/16/2010 unimed surgical products, inc., 10401 belcher road, largo, fl 33777 initiated a recall of the medline industries, inc. electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.
  • Action
    Unimed Surgical Products, Inc. issued a Medical Device Removal letter dated June 4, 2010 to Medline Industries, Inc. The letter identified the affected product, problem and actions to be taken. Medline was instructed to quarantine any undistributed product and notify its customers of the recall. For further information, contact Unimed Surgical Product, Inc. by phone 800-531-2627 or FAX 800-886-1225.

Device

Device Recall Mediline Industries, Inc.
  • Model / Serial
    Lot # 030309-02 and 030509-05
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution - including the state of IL.
  • Product Description
    Product is labeled in part: "***MEDLINE***Standard PTFE Coated Needle 2.75" (6.99cm) Length***Reorder: ES0013***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***" || Part # ES0013 -- Lot # 030309-02 and 030509-05 || Product Usage: Intended for cutting and coagulation of soft tissue.
  • 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