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
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