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Natus Neurology Inc Recall 93969

Description: TENSIVE Conductive Adhesive Gel, REF 016-401600

Natus Neurology Inc Recall 93969 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1305-2024
Event ID93969
Event DescriptionTENSIVE Conductive Adhesive Gel, REF 016-401600
Product TypeDevices
DistributionWorldwide distribution - US Nationwide and the country of Canada.
Quantity80 units
Recall ReasonNatus 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.
Device Classification20240327
Device Code InfoUDI/DI 00855683006333, Lot Numbers: A0623009
Center Classification Date20240319
Recall Initiation Date20240207
Recalling FirmNatus Neurology Inc
Initial Notification Letter
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