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Class 2 Device Recall Cognision, Subject Kit |
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Date Initiated by Firm |
November 07, 2019 |
Create Date |
December 12, 2019 |
Recall Status1 |
Terminated 3 on October 26, 2020 |
Recall Number |
Z-0675-2020 |
Recall Event ID |
84324 |
510(K)Number |
K970694
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Product Classification |
Degreaser, skin, surgical - Product Code KOY
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Product |
Cognision, Subject Kit (Clinical Grade), Model 3000- containing Hydro Dot brand Wave Prep cups-electroconductive cream for use with external electrodes. Order No. D5000, Part No. PN-1720 - Product Usage: An electroconductive cream for use with external electrodes to reduce the impedance of the contact between the electrode surface and the skin. The cream is not intended for use with stimulating electrode. The Wave Prep¿ cups are a component in the Subject Kit.
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Code Information |
Kit lot codes: NNX-100001478, NNX-100001480, NNX-100001481, NNX-100001486, NNX-100001488, NNX-100001492, NNX-100001542, NNX-100001559, NNX-100001560, NNX-100001561 (containing Wave Prep lot codes: 30656). |
Recalling Firm/ Manufacturer |
Neuronetrix Solutions, LLC dba Cognision 1044 E Chestnut St Louisville KY 40204-6033
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For Additional Information Contact |
David Richardson 502-561-9040 Ext. 7020
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Manufacturer Reason for Recall |
Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia
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FDA Determined Cause 2 |
Process control |
Action |
Cognison notified customers and/or end users via email and/or telephone. Customer who received more than 20 units of the affected Wave Prep¿ cups were initially notified by phone on 11/7/2019. All customers were then sent an email with an attached recall letter also on 11/7/2019. Letter states reason for recall, health risk and action to take:
Please review your inventory of the Subject Kit (Clinical Grade), Model 3000, Order No. D5000 and immediately discontinue use and quarantine any of the affected product with lot numbers shown above. Customers have been instructed to dispose of the affected product as medical waste. Customer to return notice via email to support@cognision.com. If you dont have any affected product, you may call Cognision Customer Service at 800-561-9040 and inform the Customer Service Representative that you have no affected product. Alternatively, you mail email support@cognision.com and provide this information |
Quantity in Commerce |
3,108 units |
Distribution |
US Nationwide distribution. |
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 = KOY and Original Applicant = PHYSIOMETRIX, INC.
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