Bio-Detek, Inc.
Zoll pedi.padz Reduced Energy Multi-Function Electrodes (MFE) Part number: 8900-0401 Used in connection with Zoll M Series and E series Defibrillators specifically for pediatric patients.
| Date | Feb 13, 2012 (initiated Dec 30, 2011) |
| Status | Terminated |
| Reason | Lack of an adequate silicone seal around the periphery of the attenuator enclosure may allow fluid to enter. |
| Root cause | Process control |
| Action | Zoll Medical issued Urgent Device Correction notices dated 12/30/11 via UPS/Registered Mail. The letter described the issue and identified the affected product. ZOLL recommended that customers alert their staff of the issue, that the electrodes should be kept away from a fluid environment, to use caution in handling the electrodes if they are subjected to a fluid environment and maintain safe defibrillation practice, and seek a replacement if available. Also customers should contact Zoll 1-800-348-9011 for product replacement. The firm plans to replace the affected lots free of charge. |
| Quantity | 3,080 units |
| Distribution | Worldwide Distribution -- US and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072430 | ZOLL PEDIPADZ REDUCED ENERGY ELECTRODE ZOLL Medical Corporation, Nov 6, 2007 |