Recall Z-1241-06 ยท MKJ Automated External Defibrillators (Non-Wearable)
Kimberly-Clark Corporation
Kimberly-Clark/Ballard medical R2 triangle shaped non-radiolucent multifunction electrode products for pediatrics.
| Date | Jul 28, 2006 (initiated May 18, 2006) |
| Status | Terminated |
| Reason | The tinfoil in the triangle electrodes has the potential to develop cracks which may hinder electrical flow and product performance during defibrillation. |
| Root cause | 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 | 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) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K895729 | R2 PACE PAD, MODEL 480 Darox Corp., Oct 12, 1989 |