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U.S. Department of Health and Human Services

Class 2 Device Recall Zoll Medical Corp

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 Class 2 Device Recall Zoll Medical Corpsee related information
Date Initiated by FirmAugust 26, 2014
Date PostedSeptember 17, 2014
Recall Status1 Terminated 3 on May 03, 2016
Recall NumberZ-2658-2014
Recall Event ID 69145
510(K)NumberK943698 
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
ProductZOLL Pro-padz Sterile Adult Multi-Function Electrodes Part number: 8900-4012 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation to a SAL of 1 o.e 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. These MFE electrodes have a 12 month shelf life from time of manufacture.
Code Information Lot Number: 2314
Recalling Firm/
Manufacturer		 Bio-Detek, Inc.
525 Narragansett Park Dr
Pawtucket RI 02861-4323
For Additional Information ContactSame
401-729-1400 Ext. 238
Manufacturer Reason
for Recall		Sterility of device is not assured
FDA Determined
Cause 2		Process control
ActionBioDetek sent an Urgent Device Correction letter dated August 26, 2014, to all affected customers via UPS overnight delivery. There has also been notifications addressed to the 4 International accounts on August 27, 2014. Customers were requested to return the suspect product(s) in their possession and complete the Device Correction Response Return Form provided to each customer. Customer inventory will be replaced as soon as replacement electrodes are processed. Customers with questions can contact the technical support numbers at 1 (800) 348-9011 or +1 (978) 421-9460 24/7. For questions regarding this recall call 401-729-1400.
Quantity in Commerce198 cases
DistributionWorldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, and Germany.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MKJ
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