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U.S. Department of Health and Human Services

Class 2 Device Recall Zoll

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  Class 2 Device Recall Zoll see related information
Date Initiated by Firm September 16, 2014
Date Posted October 09, 2014
Recall Status1 Terminated 3 on May 03, 2016
Recall Number Z-0052-2015
Recall Event ID 69409
510(K)Number K943698  
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
Product ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE)
Part Number: 8900-4012

Product Usage:
These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of 10-6 per International/ National Standards, EN ISO 11137-2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring.
Code Information Lot Numbers: 1614, 1814, 1914
Recalling Firm/
Manufacturer		 Bio-Detek, Inc.
525 Narragansett Park Dr
Pawtucket RI 02861-4323
For Additional Information Contact
401-729-1400 Ext. 238
Manufacturer Reason
for Recall		 Product sterility is not assured
FDA Determined
Cause 2		 Material/Component Contamination
Action Bio-Detek notiifed customers of the expanded recall on September 16, 2014 for Lot 1914 and September 22, 2014 for Lots 1614, 1814, 2114 via UPS overnight delivery. Customers were requested to return the suspect product(s) in their possession. A Device Correction Response Return Form was provided to each Customer. For questions call 1-800-348-9011 or 1-978-421-9460.
Quantity in Commerce 237 cases (6/case)
Distribution Worldwide Distribution - US Nationwide and the countries of: Australia, Canada, Belgium, France, and Germany.
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = MKJ and Original Applicant = ZOLL MEDICAL CORP.
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