Events

Recall of Electrosurgical, cutting & coagulation & accessories.

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

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
    35283
  • Event Risk Class
    Class 2
  • Event Number
    Z-0859-06
  • Event Initiated Date
    2006-04-21
  • Event Date Posted
    2006-05-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-02-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45717
  • 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
    Electrosurgical ablation device may experience loss of power during use, when used with cool-tip switching controller in ablation mode.
  • Action
    Consignees were notified by telephone followed by a fax on 04/21/2006.

Device

Electrosurgical, cutting & coagulation & accessories.
  • Model / Serial
    Product Number: CTRF117 and CTRF220. Lot numbers: C4K101C thru C4K122C, C4K126C thru C4K133C, C4L134C thru C4L147C, C5A148C thru C5A158C, C5B159C thru C5B174C, C5C175C thru C5C191C, C5D192C thru C5D199C, C5E200C thru C5E213C, C5F214C thru C5F231C, C5G232C thru C5G235C, C5H236C thru C5H241C, C5I242C thru C5I246C, C5J247C thru C5J263C, C5K264C thru C5K272C, C5L273C thru C5L282C, C6A283C thru C6A286C.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide. AZ, CA, CO, CT, FL, GA, IL, MA, MI, MN, MO, MS, NC, NE, NJ, OH, OK, PA, TX, VA. Foreign distribution to Argentina, Canada, Chile, Costa Rica, France, Greece, Israel, Peru, Singapore.
  • Product Description
    Cool-tip RF Generator, for use in percutaneous, laparoscopic, intraoperative coagulation and ablation of tissue.
  • Manufacturer
    Covidien LP

Manufacturer

Covidien LP
  • Manufacturer Address
    Covidien LP, 5920 Longbow Dr, Boulder CO 80301-3202
  • Source
    USFDA