| Class 2 Device Recall | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = MKJ
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