TENSIVE Conductive Adhesive Gel, REF 016-401600
This recall is currently active, issued March 19, 2024. It was issued by Natus Neurology Inc.
- Company
- Natus Neurology Inc
- Recall Initiated
- February 7, 2024
- Posted
- March 19, 2024
- Recall Number
- Z-1305-2024
- Quantity
- 80 units
- Firm Location
- Middleton, WI
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Lot / Code Info
UDI/DI 00855683006333, Lot Numbers: A0623009
Root Cause
Under Investigation by firm
Action Taken
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.