Conductive Adhesive Gel Recalled Due to Thickness and Discoloration Issues
Natus Neurology is recalling TENSIVE Conductive Adhesive Gel (Lot A0623009) after complaints of improper thickness, discoloration, and in one case, patient skin irritation following use.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This FDA Class II recall involves product quality defects (thickness and discoloration) with minimal reported adverse effects—one case of skin irritation among five total complaints. Without hospitalization reports or serious injury, this voluntary recall is classified as Moderate.
Plain-English summary
Natus Neurology Inc. is conducting a voluntary recall of TENSIVE Conductive Adhesive Gel, REF 016-401600. The product is distributed worldwide, including the United States and Canada. The recall affects 80 units bearing UDI/DI 00855683006333 and Lot Number A0623009.
Following customer complaints about product quality, Natus initiated the recall. Customers report that the gel is thicker than normal and discolored (darker than usual). Natus received five complaints regarding these issues. In one case, a patient reported skin irritation following a procedure using the affected product. These quality defects were identified by the product's supplier, Parker Laboratories Inc.
The thickness and discoloration of the product may impair its intended function in medical procedures.
The recalled product
- Product
- TENSIVE Conductive Adhesive Gel, REF 016-401600
- Manufacturer
- Natus Neurology Inc
- Hazard
- skin-irritation
- discoloration
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/DI 00855683006333
- Lot Numbers: A0623009
Distribution
Distributed nationwide across the United States.
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