CLASS II Device recall · Reported 1 Jan 2020 · FDA Enforcement Report
ElectroTek Temporal Sensor Cable Gold - Long Length, Graduated recalled
Lifelines Neuro is recalling ElectroTek Temporal Sensor Cable Gold - Long Length, Graduated, distributed nationwide in the US. The recall was initiated on 11 Oct 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0722-2020
- FDA event ID
- 84270
- Recalling firm
- Lifelines Neuro, Louisville, KY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Oct 2019
- FDA classified
- 20 Dec 2019
- Reported
- 1 Jan 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Lead & Heavy Metals
- Device type
- Test Kits & Diagnostics
Timeline
| 11 Oct 2019 | Recall initiated by company | |
| 20 Dec 2019 | Classified by FDA | +70 days |
| 1 Jan 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for one of the four temporal electrode cables used in with the ElectroTek EEG system having incorrect placement labels which could lead to incorrect placement of electrode for an EEG study.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
ElectroTek Temporal Sensor Cable Gold - Long Length, Graduated - Product Usage: The electroencephalographic system ElectroTek is intended to acquire, display, and store the electrical activity of a patient s brain obtained by placing electrodes on the patient s scalp. The ElectroTek is intended to be used for such studies as electroencephalogram (EEG) and video EEG recording to aid in diagnosis. The ElectroTek does not draw any diagnostic conclusions.
Where it was distributed
US Nationwide distribution in the states of TX, TN, NC.
Questions about this recall
Is ElectroTek Temporal Sensor Cable Gold - Long Length, Graduated recalled?
Yes. Lifelines Neuro recalled ElectroTek Temporal Sensor Cable Gold - Long Length, Graduated on 11 Oct 2019. The recall is Class II and its status is Terminated. Recall number Z-0722-2020.
Why was it recalled?
Potential for one of the four temporal electrode cables used in with the ElectroTek EEG system having incorrect placement labels which could lead to incorrect placement of electrode for an EEG study.
Which lots are affected?
UDI: 0 0856310 00635 1 Lot Code: J380188 Model Number: PL00010-29.00-31.75.33.00-35.50-G
Where was it sold?
US Nationwide distribution in the states of TX, TN, NC.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Lifelines Neuro
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | ElectroTek Temporal Sensor Cable Gold - Long Length, Single Length recalled | Lifelines Neuro | Lead & Heavy Metals | Nationwide |
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