Kimberly-Clark/Ballard medical R2 triangle shaped non-radiolucent multifunction electrode products for adults.
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-1242-06
- 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 30-585, 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.
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.