Z-1306-2024 Class II Ongoing
FDA device recall Z-1306-2024 was initiated by Natus Neurology Inc on February 7, 2024 and is designated Class II. 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 ha… The recall status is ongoing. Affected quantity: 35 units.
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
- 35 units
Product Description
natus neurology, Sleep Supplies Start Kit with Single Use Supplies for Embla EX Series Amplifiers, REF 024252
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 x, Lot Numbers: 614922, 614923, 614921, 122923, 628166