TENSIVE Conductive Adhesive Gel, REF 016-401600 recallZ-1305-2024 · Natus Neurology Inc · initiated Feb 7, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Natus Neurology Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
Natus issued an Urgent Medical Device Recall Notice to its consignees on 02/07/2024 via UPS and email. The notice explained the issue and risk to health. It also requested the consignee cease use, complete and return the form for the replacement of the product.
Recall details
- Recall number
- Z-1305-2024
- Status
- Open, Classified
- Initiated by the company
- Feb 7, 2024
- Posted by the FDA
- Mar 19, 2024
- Recalling firm
- Natus Neurology Inc
- Quantity
- 80 units
- Product code
- GYB
- FDA submissions
- K852956
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
Product description
TENSIVE Conductive Adhesive Gel, REF 016-401600
Code information (models, lots, serial numbers)
UDI/DI 00855683006333, Lot Numbers: A0623009
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- TENSIVE CONDUCTIVE ADHESIVE GELParker Laboratories Inc · Media, Electroconductive2 recalls0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 93969).
- Z-1306-2024 · Open, Classifiednatus neurology, Sleep Supplies Start Kit with Single Use Supplies for Embla EX Series Amplifiers, REF 024252
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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