Cognision Subject Kit Recalled for Potential B. cepacia Contamination
Neuronetrix Solutions is recalling 3,108 units of the Cognision Subject Kit (Clinical Grade) due to potential contamination with Burkholderia cepacia.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls with potential for significant injury or hospitalization (implied by the pathogen) are rated as Severe (4).
Plain-English summary
Neuronetrix Solutions, LLC dba Cognision is recalling 3,108 units of the Cognision, Subject Kit (Clinical Grade), Model 3000. The kit contains Hydro Dot brand Wave Prep cups, which are an electroconductive cream used with external electrodes to reduce impedance between the electrode surface and the skin. The product is distributed nationwide in the United States.
The recall was initiated because the product has the potential to be contaminated with Burkholderia cepacia (B. cepacia). The affected kits have lot codes NNX-100001478, NNX-100001480, NNX-100001481, NNX-100001486, NNX-100001488, NNX-100001492, NNX-100001542, NNX-100001559, NNX-100001560, and NNX-100001561, and contain Wave Prep lot code 30656.
The U.S. Food and Drug Administration has classified this as a Class II recall. Consumers and healthcare providers should stop using the affected kits and contact the recalling firm for instructions on return or replacement.
The recalled product
- 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 i
- Manufacturer
- Neuronetrix Solutions, LLC dba Cognision
- Hazard
- Affected units
- 3,108
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- 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).
Distribution
Distributed nationwide across the United States.
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