Health product recall

Disposable Subdermal Eeg Needle Electrode

Brand(s)
Last updated

Summary

Product
Disposable Subdermal Eeg Needle Electrode
Issue
Medical devices - Mechanical defect
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products Lot or serial number Model or catalog number
Disposable Subdermal Eeg Needle Electrode 49192 TE/S50715-001
Disposable Subdermal Eeg Needle Electrode 49429
Disposable Subdermal Eeg Needle Electrode 50106

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. 

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Neurology
Companies
Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63788