Reported Mar 27, 2024 · Ongoing
TENSIVE Conductive Adhesive Gel, REF 016-401600
Natus Neurology Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Natus Neurology Inc · 3150 Pleasant View Rd · Middleton, WI · 53562-4800
Is this the product you have?
- TENSIVE Conductive Adhesive Gel, REF 016-401600
- Lot codes and dates
- UDI/DI 00855683006333
- Lot NumbersA0623009
- Amount recalled
- 80 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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