Z-1241-06

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

Name: Z-1241-06 Kimberly-Clark/Ballard medical R2 triangle shaped non-radiolucent multifunction electrode products for...
Creator: Kimberly-Clark Corporation
Published: 2006-05-18
License: https://open.fda.gov/license/

Kimberly-Clark Corporation / initiated 2006-05-18 / Terminated / root cause: design

FDA source

Kimberly-Clark Corporation began a recall of Kimberly-Clark/Ballard medical R2 triangle shaped non-radiolucent multifunction electrode products for pediatrics on 2006-05-18. The reason FDA records is "The tinfoil in the triangle electrodes has the potential to develop cracks which may hinder electrical flow and product performance during defibrillation". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1241-06
Status: Terminated
Initiated: 2006-05-18
Posted: 2006-07-28
Terminated: 2007-05-14
Recalling firm: Kimberly-Clark Corporation
Product: Kimberly-Clark/Ballard medical R2 triangle shaped non-radiolucent multifunction electrode products for pediatrics.
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: The tinfoil in the triangle electrodes has the potential to develop cracks which may hinder electrical flow and product performance during defibrillation.
Root cause tag: design
FDA 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 in commerce: 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)
Product codes and lots: 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.

Product code MKJ

K895729Class IIR2 Pace Pad, Model 480Darox Corp. / cleared 1989-10-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)