Natus Neurology Inc recalls TENSIVE Conductive Adhesive Gel, REF 016-401600

Recall date

February 7, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1305-2024

FDA classification

Class II

Brand / firm

Natus Neurology Inc

Sold / distributed

Worldwide distribution - US Nationwide and the country of Canada.

Why it was recalled

Natus has become aware that its third-party supplier Parker Laboratories Inc. is conducting a voluntary recall related to their Tensive Conductive Adhesive Gel, Ref. 22-60 Lot Number A0623009. They have received five complaints. These customers reported that the gel is too thick, is discolored (darker than usual), and in one instance, patients reported irritation after procedures using the gel.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

TENSIVE Conductive Adhesive Gel, REF 016-401600