Events

Recall of Endopath Probe Plus II, Spatula Electrode, 5mm shaft, 34 cm length, hollow tip electrode

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ethicon Endo-Surgery 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
    35228
  • Event Risk Class
    Class 2
  • Event Number
    Z-0919-06
  • Event Initiated Date
    2006-04-20
  • Event Date Posted
    2006-05-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45564
  • 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
    Spatula Electrode - Product Code GCJ
  • Reason
    There is the possibility of a seal void in the probe plus packaging which may have compromised the sterility of the device.
  • Action
    The recalling firm sent a recall letter by United Parcel Services to all consignees for delivery to each consignee on 4/24/06. The letter requested subaccount address return information to the recalling firm.

Device

Endopath Probe Plus II, Spatula Electrode, 5mm shaft, 34 cm length, hollow tip electrode
  • Model / Serial
    Lot C4DK34 and C4DK9L.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The recalled product was distributed throughout the United States and to foreign consignees including Argentina, Australia, Austria, Bahrain, Brazil, Canada, China, Colombia, Czech Republic, Dominican Republic, Ecuador, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Korea, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Pakistan, Peru, Philippines, Poland, Portugal, Puerto Rico, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Uruguay, Venezuela.
  • Product Description
    Endopath Probe Plus II, Spatula Electrode, 5mm shaft, 34 cm length, hollow tip electrode, Product Code EPS02.
  • Manufacturer
    Ethicon Endo-Surgery Inc

Manufacturer

Ethicon Endo-Surgery Inc
  • Manufacturer Address
    Ethicon Endo-Surgery Inc, 4545 Creek Rd, Cincinnati OH 45242-2803
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA