TENSIVE Conductive Adhesive Gel, REF 016-401600
Reported: March 27, 2024 Initiated: February 7, 2024 #Z-1305-2024
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.
Details
- Recalling Firm
- Natus Neurology Inc
- Units Affected
- 80 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Location
- Middleton, WI
Frequently Asked Questions
What product was recalled? ▼
TENSIVE Conductive Adhesive Gel, REF 016-401600. Recalled by Natus Neurology Inc. Units affected: 80 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 27, 2024. Severity: Moderate. Recall number: Z-1305-2024.
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