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U.S. Department of Health and Human Services

Class 2 Device Recall Electrode Adaptor Caple QuickCombo System

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 Class 2 Device Recall Electrode Adaptor Caple QuickCombo Systemsee related information
Date Initiated by FirmJanuary 23, 2008
Date PostedSeptember 17, 2008
Recall Status1 Terminated 3 on December 08, 2011
Recall NumberZ-1714-2008
Recall Event ID 47224
510(K)NumberK010214 
Product Classification Electrode - Product Code MKJ
ProductElectrode Adaptor Cable Quick-Combo System, Model 9055 The 9055 Electrode Adaptor is intended for use by trained personnel who use a Cardiac Science Automated External Defibrillator (AED) for defibrillation with Medtronic QUICK-COMBO Electrodes.
Code Information Lot numbers: 123004, 92804, 62305, 63005, 52504, 50405, 33105, 12605, 12505, 7715, 6952, and 6838
FEI Number 2112020
Recalling Firm/
Manufacturer		 Cardiac Science Corporation
3303 Monte Villa Pkwy
Bothell WA 98021-8969
For Additional Information ContactBev Magrane
425-402-2000
Manufacturer Reason
for Recall		Instructions For Use is not clear about how the AED voice and text prompts will differ when the adapter is used.
FDA Determined
Cause 2		Labeling design
ActionOn 1/23/08 the firm issued a letter titled "9055 Electrode Adaptor IFU Update" to consignees sent via certified return receipt requested. Enclosed with the letter is an updated Instructions For Use, part number 70-00180-01, revision C. Consignees were advised to discard their old Instructions For Use. For assistance, contact Cardiac Science at 1-888-466-8686.
Quantity in Commerce63
DistributionDistributed Nationwide US and Canada and Internationally to: Norway and Guam
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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