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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = MKJ
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