Public recall detail

Disposable Subdermal Eeg Needle Electrode

medium
Recall Safety notice
Quick summary

Quick summary: Disposable Subdermal Eeg Needle Electrode.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Disposable Subdermal Eeg Needle Electrode.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandTechnomed Europe
ProductDisposable Subdermal Eeg Needle Electrode
IssueMedical devices - Mechanical defect
Recall classType II
IdentificationRA-63788

Affected products

ProductDisposable Subdermal Eeg Needle Electrode
Lot49192
ModelTE/S50715-001
Serial number49192
DescriptionDisposable Subdermal Eeg Needle Electrode
ProductDisposable Subdermal Eeg Needle Electrode
Lot49429
Serial number49429
DescriptionDisposable Subdermal Eeg Needle Electrode
ProductDisposable Subdermal Eeg Needle Electrode
Lot50106
Serial number50106
DescriptionDisposable Subdermal Eeg Needle Electrode

Issue

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.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceGeneral public Health professionals Hospitals
CategoryHealth products - Medical devices - Neurology
CompaniesPublished by Health Canada
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-63788
Background{}
CompaniesPublished by Health Canada
AudiencesGeneral public Health professionals Hospitals
Source updated2022-01-04

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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