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Disposable subdermal eeg needle electrode

Official notice

4 Jan 2022

Last checked

4 Jan 2022

Medium riskHealth Canada

An official Health Canada notice concerns Disposable subdermal eeg needle electrode. On 10 November 2021, a Corkscrew Needle Electrode dislodged from the wire and hub; and had to be removed from the patient's scalp by making a small incision (NCR 21-081). Later on, NCR 21-087 was received in which the needle had to be removed from the patient's scalp by using a forceps. In two other complaints, the needle could not be inserted. A recall was started on 25 November 2021, not affecting the territory of Canada. It was decided to extend the recall on 21st of December 2021, now affecting Canada. Recall start date: December 21, 2021. Published 2022-01-04.

What to do now

Contact the manufacturer if you require additional information.

Recall number

63788

Official notice

2022-01-04

The hazard

On 10 November 2021, a Corkscrew Needle Electrode dislodged from the wire and hub; and had to be removed from the patient's scalp by making a small incision (NCR 21-081). Later on, NCR 21-087 was received in which the needle had to be removed from the patient's scalp by using a forceps. In two other complaints, the needle could not be inserted. A recall was started on 25 November 2021, not affecting the territory of Canada. It was decided to extend the recall on 21st of December 2021, now affecting Canada. Recall start date: December 21, 2021.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

63788

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Affected products

Product 1

Affected Products - Disposable Subdermal Eeg Needle Electrode, Lot or serial number - 49192, Model or catalog number - TE/S50715-001

Product 2

Affected Products - Disposable Subdermal Eeg Needle Electrode, Lot or serial number - 49429

Product 3

Affected Products - Disposable Subdermal Eeg Needle Electrode, Lot or serial number - 50106

Risk / hazard

On 10 November 2021, a Corkscrew Needle Electrode dislodged from the wire and hub; and had to be removed from the patient's scalp by making a small incision (NCR 21-081). Later on, NCR 21-087 was received in which the needle had to be removed from the patient's scalp by using a forceps. In two other complaints, the needle could not be inserted. A recall was started on 25 November 2021, not affecting the territory of Canada. It was decided to extend the recall on 21st of December 2021, now affecting Canada. Recall start date: December 21, 2021.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Technomed, Disposable Subdermal Eeg Needle Electrode.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

63788

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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