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U.S. Department of Health and Human Services

Class 3 Device Recall 9051 Electrode Adapter

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  Class 3 Device Recall 9051 Electrode Adapter see related information
Date Initiated by Firm January 23, 2008
Date Posted May 21, 2008
Recall Status1 Terminated 3 on July 21, 2011
Recall Number Z-1616-2008
Recall Event ID 47205
510(K)Number K971149  
Product Classification Automated external defibrillator - Product Code MKJ
Product 9051 Electrode Adapter; Automated external defibrillator, Used with QUIK-COMBO System; Cardiac Science Corp, Bothell, WA 98021.
Code Information Lot Numbers: W029275 and W029476.
Recalling Firm/
Manufacturer		 Cardiac Science Corporation
3303 Monte Villa Pkwy
Bothell WA 98021-8969
For Additional Information Contact Beverly A. Magrane
425-402-2000
Manufacturer Reason
for Recall		 Adaptor Cable Incorrectly Manufactured: The red and white connector ends of the adapter are switched. Therefore, the cable will not connect to the electrodes as indicated in the instructions.
FDA Determined
Cause 2		 Process control
Action Consignees were notified by an Urgent Medical Device Recall letter sent on 01/23/2008. The letter instructs users to check each cable of the affected lot to ensure that it properly connects to the electrode. Users were also instructed to return any defective product to the recalling firm for a replacement. For additional information, contact 1-888-466-8686 x2041.
Quantity in Commerce Lot W029275 - 24; Lot W029475 - 38
Distribution Nationwide Distribution including states of CT, IA, IN, NC, NY, OH, PA, WA, and WI.
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 = SURVIVALINK CORP.
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