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U.S. Department of Health and Human Services

Class 2 Device Recall Cognision, Subject Kit

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  Class 2 Device Recall Cognision, Subject Kit see related information
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  
Product Classification Degreaser, skin, surgical - Product Code KOY
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.
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
For Additional Information Contact David Richardson
502-561-9040 Ext. 7020
Manufacturer Reason
for Recall		 Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia
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
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 = KOY and Original Applicant = PHYSIOMETRIX, INC.
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