Natus Neurology Inc. is recalling approximately 115 units of Tensive Conductive Adhesive Gel and Sleep Supplies Start Kits because the gel may be discolored, too thick, and can cause skin irritation. The issue was discovered after five complaints were received regarding the gel's texture and appearance, including one report of patient skin irritation following a procedure. These products were distributed worldwide, specifically across the United States and Canada, and involve specific lots of the Tensive gel and Embla EX Series amplifier kits.
The defective gel can cause localized skin irritation or discomfort for patients during or after medical procedures. Additionally, the abnormal thickness and discoloration of the gel may interfere with the proper performance of medical diagnostic equipment.
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Sources: FDA iRES · Raw API Response
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