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U.S. Department of Health and Human Services

Class 2 Device Recall Zoll pedi.padz Reduced Energy MultiFunction Electrodes (MFE)

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 Class 2 Device Recall Zoll pedi.padz Reduced Energy MultiFunction Electrodes (MFE)see related information
Date Initiated by FirmDecember 30, 2011
Date PostedFebruary 13, 2012
Recall Status1 Terminated 3 on December 11, 2012
Recall NumberZ-1011-2012
Recall Event ID 60835
510(K)NumberK072430 
ProductZoll 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.
Code Information Lot Numbers 0510 thru 4511
Recalling Firm/
Manufacturer		 Bio-Detek, Inc.
525 Narragansett Park Dr
Pawtucket RI 02861-4323
For Additional Information Contact
401-729-1400
Manufacturer Reason
for Recall		Lack of an adequate silicone seal around the periphery of the attenuator enclosure may allow fluid to enter.
FDA Determined
Cause 2		Process control
ActionZoll 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 in Commerce3,080 units
DistributionWorldwide Distribution -- US and Canada.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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