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Health Canada Medical devices

Disposable Subdermal Eeg Needle Electrode

Issued January 4, 2022
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.
Hazard description
Mechanical defect
Product
Product name
Disposable Subdermal Eeg Needle Electrode
Reference
ID
RA-63788