Recall Z-1011-2012
Bio-Detek, Inc. · initiated December 30, 2011
Product
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.
Codes / lots: Lot Numbers 0510 thru 4511
Reason for recall
Lack of an adequate silicone seal around the periphery of the attenuator enclosure may allow fluid to enter.
FDA-determined 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.
Details
- Recall number
- Z-1011-2012
- Initiated
- December 30, 2011
- Posted by FDA
- February 13, 2012
- Terminated
- December 11, 2012
- Quantity
- 3,080 units
- Distribution
- Worldwide Distribution -- US and Canada.
- Recalling firm
- Bio-Detek, Inc., Pawtucket, RI