Kimberly-Clark/Ballard medical R2 triangle shaped non-radiolucent multifunction electrode products for pediatrics.
FDA device recall Z-1241-06 · posted 2006-07-28 · Terminated
Recall details
- Recalling firm
- Kimberly-Clark Corporation
- 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.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 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)
- Date initiated
- 2006-05-18
- Date posted
- 2006-07-28
- Date terminated
- 2007-05-14
- Location
- Roswell, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| R2 PACE PAD, MODEL 480 (K895729) | Darox Corp. | 1989-10-12 |