Events

Recall of Device Recall Urethral Warmer System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Galil 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
    57254
  • Event Risk Class
    Class 2
  • Event Number
    Z-0832-2011
  • Event Initiated Date
    2010-11-11
  • Event Date Posted
    2010-12-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95676
  • 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
    Unit, cryosurgical, accessories - Product Code GEH
  • Reason
    This voluntary recall has been initiated because our supplier (gaymar industries, inc.) notified us that these products contain power cords that may crack or fail at or inside the plug due to a prong design problem. affected plugs can be identified by a round ground pin and black plastic bridges. cords with plugs that are not affected have u-shaped ground pins and no plastic bridges. although gali.
  • Action
    Gaymar sent an URGENT: MEDICAL DEVICE RECALL letter dated September 30, 2010, to all consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: Customers were instructed to: " Inspect units in their possession to determine if they contain affected power cord plugs or if there were any signs of excessive wear or damage. " Immediately discontinue use and quarantine the affected product. " Contact Customer Service Department at 800-828-7341 to arrange for replacement. " Complete the attached form for each unit and follow the instructions given to return the form by fax or e-mail. " If customers further distributed the product to another person or entity, they were to identify their customers and notify them at once of this product recall by including a copy of the recall notification letter and the attached form. For questions regarding this recall call 800-828-7341 or 716-662-2551.

Device

Device Recall Urethral Warmer System
  • Model / Serial
    GW469, GW470, GW468, GW472
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA, including CA, GA, TX and the country of Canada.
  • Product Description
    Urethral Warmer System Model number FPRCH3001 || The Urethral Warming System is designed to circulate a warm solution through a warming catheter to maintain urethral tissue near body temperatures while the surrounding prostate tissue is being frozen. It is intended to warm urethral tissue when performing cryogenic destruction of prostatic tissue with a Galil Medical Cryoablation System.
  • Manufacturer
    Galil Medical

Manufacturer

Galil Medical
  • Manufacturer Address
    Galil Medical, 4364 Round Lake Road, Arden Hills MN 55112
  • Manufacturer Parent Company (2017)
    Btg Plc
  • Source
    USFDA