Events

Recall of Kimberly-Clark/Ballard medical R2 triangle shaped non-radiolucent multifunction electrode products for adults.

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
    35559
  • Event Risk Class
    Class 2
  • Event Number
    Z-1242-06
  • Event Initiated Date
    2006-05-18
  • Event Date Posted
    2006-07-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-05-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46395
  • 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
    Automated External Defibrillators (Non-Wearable) - Product Code MKJ
  • Reason
    The tinfoil in the triangle electrodes has the potential to develop cracks which may hinder electrical flow and product performance during defibrillation.
  • Action
    Consignees were first contacted by phone with follow up letter sent via fax or mail on May 18, 2006. International consignees will be notified through the firm's regional offices.

Device

Kimberly-Clark/Ballard medical R2 triangle shaped non-radiolucent multifunction electrode product...
  • Model / Serial
    Catalog number 30-585, Lot number 300847; Catalog number 30-590 Lot numbers 28802, 297261, 304750; Catalog number 30-591, Lot number 299214; Catalog number 30-593, Lot number 288962, 293213, 294860, 302657; Catalog number 3100-1702, Lot number 297735; Catalog number 3100-703, Lot number 282936, 293214, 300849, 303000; Catalog number 3111-1721, Lot numbers 282181, 282938, 286332, 286339, 288964, 288970, 290318, 290905, 291535, 292660, 293217, 294206, 294862, 295600, 296270, 297263, 298032, 299985, 302659, 303003, 304091, 304753, 305509;  Catalog number 3112-1731, Lot numbers 282183, 282939, 285955, 286335, 286342, 290320, 290907, 291537, 292662, 293220, 294208, 294866, 295603, 296273, 299218, 299987, 300853, 304093, 305512; Catalog number 3114-1741, Lot numbers 282185, 284030, 290322, 291538, 292664, 295604, 297266, 300854, 304095; Catalog number 3200-1715, Lot numbers 282188, 282942, 284031, 288004, 288005, 288966, 288967, 288974, 288975, 290911, 291541, 292667, 293224, 294210 294870, 295607, 296276, 297269, 298038, 299221, 299991, 301444, 302665, 303008, 304097, 304757, 305515;  Catalog number 3250-1780, Lot numbers 292086, 297270, 301445, 302666.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide ( including USA, Switzerland, Germany, UK, Canada, Australia, Netherlands, Italy, Greece, Spain, Hong Kong, Hungary, Denmark, Singapore, New Zealand, Ireland, Korea)
  • Product Description
    Kimberly-Clark/Ballard medical R2 triangle shaped non-radiolucent multifunction electrode products for adults.
  • Manufacturer
    Kimberly-Clark Corporation

Manufacturer

Kimberly-Clark Corporation
  • Manufacturer Address
    Kimberly-Clark Corporation, 1400 Holcomb Bridge Rd, Roswell GA 30076
  • Source
    USFDA