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Recall Observatory FDA recall evidence

Device product

TENSIVE Conductive Adhesive Gel, REF 016-401600

Z-1305-2024

February 07, 2024

Class II

Product summary

Firm
Natus Neurology Inc
Event
Event 93969
Status
Ongoing
Classification
Class II
Quantity
80 units
Official record key
device-enforcement:Z-1305-2024

Official wording

Reason: 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.

Code information: UDI/DI 00855683006333, Lot Numbers: A0623009

Distribution pattern: Worldwide distribution - US Nationwide and the country of Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.