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Natus Neurology Inc recalls TENSIVE Conductive Adhesive Gel, REF 016-401600
Recalled March 27, 2024 · FDA recall Z-1305-2024 · Natus Neurology
Hazard
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. · FDA Class II
Units
80 units
Sold at
Worldwide distribution - US Nationwide and the country of Canada.
Description
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.
Product
TENSIVE Conductive Adhesive Gel, REF 016-401600
Manufacturer(s)
Natus Neurology Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →