Middleton, WI, United States
Natus Neurology Inc recalls
2 recalls recorded since 2018, most recently on 7 February 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 7 February 2024
- 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.
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1305-2024, Z-1306-2024
- TENSIVE Conductive Adhesive Gel, REF 016-401600
- natus neurology, Sleep Supplies Start Kit with Single Use Supplies for Embla EX Series Amplifiers, REF 024252
Terminated Class II Medical devices
- Recall started
- 1 February 2018
- Terminated
- 21 October 2022
- Reason
- Potential to be able to import an ambulatory exam for a patient for which the exam was not started.
- Distribution
- Distributed domestically to AR, AZ, CA, CO, DC, FL, GA, ID, IL, IN, MA, ME, MI, MO, N Y, NC, ND, NJ, NV, NY, PA, TN, TX, VA, WA, WI. Distributed internationally to Australia, Belgium, China, Germany, Hong Kong, Israel, Italy, Jordan, Kuwait, Russia, Slovenia, Tunisia, United Arab Emirates, Viet
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2568-2018
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.