FDA (Devices) recall action 93969
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Natus Neurology is recalling TENSIVE Conductive Adhesive Gel (Lot A0623009) after complaints of improper thickness, discoloration, and in one case, patient skin irritation following use.
Natus Neurology is recalling Sleep Supplies Start Kits due to defective conductive adhesive gel supplied by Parker Laboratories. The gel is too thick, discolored, and caused patient irritation in at least one case.