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.
This recall has been terminated (originally issued February 13, 2012).
- Company
- Bio-Detek, Inc.
- Recall Initiated
- December 30, 2011
- Posted
- February 13, 2012
- Terminated
- December 11, 2012
- Recall Number
- Z-1011-2012
- Quantity
- 3,080 units
- Firm Location
- Pawtucket, RI
- Official Source
- View on FDA website ↗
Reason for Recall
Lack of an adequate silicone seal around the periphery of the attenuator enclosure may allow fluid to enter.
Distribution
Worldwide Distribution -- US and Canada.
Lot / Code Info
Lot Numbers 0510 thru 4511
Root Cause
Process control
Action Taken
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.