FDA recall Z-1305-2024

Natus Neurology Inc · Class II · device

Product

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

Worldwide distribution - US Nationwide and the country of Canada.

Key facts

Status
Ongoing
Initiation date
2024-02-07
Report date
2024-03-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Middleton, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1305-2024