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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84324

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
November 07, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Neuronetrix Solutions, LLC dba Cognision

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-0675-2020
Recall number
Z-0675-2020
Initiated
November 07, 2019
Classification
Class II
Status
Terminated
Quantity
3,108 units

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
contaminated with Burkholderia cepacia

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia

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).

Distribution pattern

US Nationwide distribution.