Events

Recall of KimberlyClark RadiOpaque Radiofrequency Cannula

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Kimberly-Clark Corporation.

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
    66832
  • Event Risk Class
    Class 2
  • Event Number
    Z-0850-2014
  • Event Initiated Date
    2013-10-29
  • Event Date Posted
    2014-01-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-09-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123686
  • 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
    Probe, radiofrequency lesion - Product Code GXI
  • Reason
    Product may contain a cannula with an active tip length of only 5mm rather than 10mm as indicated on the label.
  • Action
    The firm, Kimberly-Clark Corporation, sent an "URGENT: Voluntary Medical Device Recall Notification" letter dated October 29, 2013 to all direct customers and distributors via federal express priority overnight. The letter described the product, problem and actions to be taken. The customers were instructed to evaluate your Facility's inventory of Kimberly-Clark RadiOpaque Radiofrequency Cannula to determine if any of the two impacted product lots remain within your facility. If product is present, discontinue use of the impacted product and place in a quarantined location; complete and return the attached Product Recall Response Form-Customers via fax to: 1-920-225-4182 within five (5) business days of receipt of this letter (complete and return form even if either of the impacted product lots is NOT present in your facility). Once response form is received, a Kimberly-Clark representative will contact you regarding return and replacement of the product. If you require further assistance, please call Kimberly-Clark Customer Service at 800-KC-HELPS (800-524-3577).

Device

KimberlyClark RadiOpaque Radiofrequency Cannula
  • Model / Serial
    Lot M3085K301 and M2327K301
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution in states of: AZ, CA, DE, FL, LA, MD, MA, NJ, NY, OH, PA and TX.
  • Product Description
    Kimberly-Clark RadiOpaque Radiofrequency Cannula, Gauge 22, Length 100 mm, Active Tip 10 mm, Distributed in the US by Kimberly-Clark,Product code PMF22-100-10 || The product is used to create lesions in nervous tissue when used with the Kimberly-Clark radiofrequency generator and probes.
  • Manufacturer
    Kimberly-Clark Corporation

Manufacturer

Kimberly-Clark Corporation
  • Manufacturer Address
    Kimberly-Clark Corporation, 1400 Holcomb Bridge Rd, Roswell GA 30076-2190
  • Manufacturer Parent Company (2017)
    Kimberly-Clark Corporation
  • Source
    USFDA