Z-1305-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- March 27, 2024
- Initiation Date
- February 7, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 80 units
Product Description
TENSIVE Conductive Adhesive Gel, REF 016-401600
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 Pattern
Worldwide distribution - US Nationwide and the country of Canada.
Code Information
UDI/DI 00855683006333, Lot Numbers: A0623009