FDA-Device2024-03-27Class II
TENSIVE Conductive Adhesive Gel, REF 016-401600
Natus Neurology Inc
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.
Sold states
Worldwide distribution - US Nationwide and the country of Canada.
Affected count
80 units
Manufactured in
3150 Pleasant View Rd, Middleton, WI, United States
Products
TENSIVE Conductive Adhesive Gel, REF 016-401600
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1305-2024Don't want to check this manually?
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