Events

Recall of Device Recall Electrosurgery Accessory

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
    34573
  • Event Risk Class
    Class 2
  • Event Number
    Z-0772-06
  • Event Initiated Date
    2006-01-27
  • Event Date Posted
    2006-04-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-08-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44119
  • 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
    Sealing cycle may be interrupted during vessel ligation procedure, resulting in an incomplete seal.
  • Action
    Consignees were notified by letter on 01/27/2006.

Device

Device Recall Electrosurgery Accessory
  • Model / Serial
    Catalog Number LS1100. Lot Numbers: Any lot number beginning with U, N2, N3, N4, or N5A through N5L247K.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, including 52 VA facilities and 12 military facilities. Foreign distribution to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Curacao, Germany, Guatamala, Israel, Japan, Mexico, Paraguay, Peru, Singapore, South Africa, Uruguay, Venezuela.
  • Product Description
    LigaSure Atlas Laparoscopic Vessel Sealer/Divider
  • Manufacturer
    Covidien LP

Manufacturer

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