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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 Adaptersee related information
Date Initiated by FirmJanuary 23, 2008
Date PostedMay 21, 2008
Recall Status1 Terminated 3 on July 21, 2011
Recall NumberZ-1616-2008
Recall Event ID 47205
510(K)NumberK971149 
Product Classification Automated external defibrillator - Product Code MKJ
Product9051 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 ContactBeverly 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
ActionConsignees 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 CommerceLot W029275 - 24; Lot W029475 - 38
DistributionNationwide Distribution including states of CT, IA, IN, NC, NY, OH, PA, WA, and WI.
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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