FDA Medical Device Recalls (openFDA)
Kimberly-Clark Corporation: Kimberly-Clark/Ballard medical R2 triangle shaped non-radiolucent multifunction electrode products for pediatrics.
- Recall number
- Z-1241-06
- Recalling firm
- Kimberly-Clark Corporation
- Product
- Kimberly-Clark/Ballard medical R2 triangle shaped non-radiolucent multifunction electrode products for pediatrics.
- 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 30-595, Lot number 288003; Catalog number 3100-1700, Lot numbers 284026 and 299215; Catalog number 3111-1720, Lot numbers 288963, 288969, 290317, 291534, 293216, 294205, 295161, 296269, 298031, 300851, 301438, 303002, 304752, 305508; Catalog number 3112-1730, Lot number 282182, 286334, 286341, 290319, 290906, 291536, 293219, 294865, 295602, 296272, 298034, 299217, 301440, 302660, 303005, 305511; Catalog number 3114-1740, Lot numbers 290321, 297265 and 302661; Catalog number 3200-1711, Lot numbers 282187, 282941, 288973, 290910, 291540, 292666, 293223, 294209, 294869, 295606, 297268, 298037, 299990, 300856, 301443, 302664, 303007, 305514.
- 510(k) numbers
- ["K895729"]
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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