FDA Medical Device Recalls (openFDA)
Kimberly-Clark Corporation: Kimberly-Clark/Ballard medical R2 triangle shaped non-radiolucent multifunction electrode products for adults.
- Recall number
- Z-1242-06
- Recalling firm
- Kimberly-Clark Corporation
- Product
- Kimberly-Clark/Ballard medical R2 triangle shaped non-radiolucent multifunction electrode products for adults.
- Status
- Terminated
- Initiated
- 2006-05-18
- Posted
- 2006-07-28
- Terminated
- 2007-05-14
- Reason
- The tinfoil in the triangle electrodes has the potential to develop cracks which may hinder electrical flow and product performance during defibrillation.
- Root cause
- Device Design
- 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.
- Quantity
- 95,639 electrode sets
- Distribution
- Worldwide ( including USA, Switzerland, Germany, UK, Canada, Australia, Netherlands, Italy, Greece, Spain, Hong Kong, Hungary, Denmark, Singapore, New Zealand, Ireland, Korea)
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K935371"]
- PMA numbers
- not on file
- Product code
- MKJ
- Firm FEI
- 1000015879
- Firm city
- Roswell
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28