Natus Neurology Inc: natus neurology, Sleep Supplies Start Kit with Single Use Supplies for Embla EX Series Amplifiers, REF 024252

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide distribution - US Nationwide and the country of Canada. Quantity: 35 units Lot/code info: UDI/DI x, Lot Numbers: 614922, 614923, 614921, 122923, 628166

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.