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.
Recall
- Recall Number
- Z-1011-2012
- Event Number
- 60835
- Firm
- Bio-Detek, Inc.
- FEI Number
- 1218058
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- December 30, 2011
- Posted
- February 13, 2012
- Terminated
- December 11, 2012
- Address
- 525 Narragansett Park Dr, Pawtucket, RI, 02861-4323
Description
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.
Lack of an adequate silicone seal around the periphery of the attenuator enclosure may allow fluid to enter.
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.
Worldwide Distribution -- US and Canada.
3,080 units