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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmMay 18, 2006
Date PostedJuly 28, 2006
Recall Status1 Terminated 3 on May 14, 2007
Recall NumberZ-1242-06
Recall Event ID 35559
510(K)NumberK935371 
Product Classification Automated External Defibrillators (Non-Wearable) - Product Code MKJ
ProductKimberly-Clark/Ballard medical R2 triangle shaped non-radiolucent multifunction electrode products for adults.
Code Information 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. 
FEI Number 1000015879
Recalling Firm/
Manufacturer		 Kimberly-Clark Corporation
1400 Holcomb Bridge Rd
Roswell GA 30076
For Additional Information ContactSally A. Herrick
770-587-7244
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionConsignees 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 Commerce95,639 electrode sets
DistributionWorldwide ( including USA, Switzerland, Germany, UK, Canada, Australia, Netherlands, Italy, Greece, Spain, Hong Kong, Hungary, Denmark, Singapore, New Zealand, Ireland, Korea)
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = MKJ
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