Kimberly-Clark/Ballard medical R2 triangle shaped non-radiolucent multifunction electrode products for pediatrics.
This recall has been terminated (originally issued July 28, 2006).
- Company
- Kimberly-Clark Corporation
- Recall Initiated
- May 18, 2006
- Posted
- July 28, 2006
- Terminated
- May 14, 2007
- Recall Number
- Z-1241-06
- Quantity
- 95,639 electrode sets
- Firm Location
- Roswell, GA
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide ( including USA, Switzerland, Germany, UK, Canada, Australia, Netherlands, Italy, Greece, Spain, Hong Kong, Hungary, Denmark, Singapore, New Zealand, Ireland, Korea)
Lot / Code Info
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.
Root Cause
Device Design
Action Taken
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.