Recall Z-1306-2024— Natus Neurology Inc

Name: FDA recall Z-1306-2024
Creator: U.S. Food and Drug Administration
Published: 2024-02-07

Class II · Ongoing

Class II FDA medical device recall by Natus Neurology Inc, initiated 2024-02-07. It names one FDA 510(k) clearance: K852956. Product: natus neurology, Sleep Supplies Start Kit with Single Use Supplies for Embla EX Series Amplifiers, REF 024252. Reason: 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..

Recalling firm: Natus Neurology Inc
Classification: Class II
Status: Ongoing
Initiated: 2024-02-07
Firm location: Middleton, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K852956 — CONTACT CONDUCTIVE ADHESIVE GEL COMPOSITIONParker Laboratories, Inc.·cleared 1985-08-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.