Medical Device Recall: natus neurology, Sleep Supplies Start Kit with Single Use Supplies for Embla EX Series Amplifiers, REF 024252
Natus Neurology Inc · February 7, 2024
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.
States Affected
NATIONWIDE
Quantity Affected
35 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1306-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.