TENSIVE Conductive Adhesive Gel recall
TENSIVE Conductive Adhesive Gel, REF 016-401600
Why was TENSIVE Conductive Adhesive Gel 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI 00855683006333, Lot Numbers: A0623009
- Product
- TENSIVE Conductive Adhesive Gel, REF 016-401600
- Recalling firm
- Natus Neurology Inc
- Quantity
- 80 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Recall date
- March 27, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)