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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm May 18, 2006
Date Posted July 28, 2006
Recall Status1 Terminated 3 on May 14, 2007
Recall Number Z-1241-06
Recall Event ID 35559
510(K)Number K895729  
Product Classification Automated External Defibrillators (Non-Wearable) - Product Code MKJ
Product Kimberly-Clark/Ballard medical R2 triangle shaped non-radiolucent multifunction electrode products for pediatrics.
Code Information 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. 
Recalling Firm/
Manufacturer		 Kimberly-Clark Corporation
1400 Holcomb Bridge Rd
Roswell GA 30076
For Additional Information Contact Sally 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
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)
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = MKJ and Original Applicant = DAROX CORP.
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