Trackx Technology Inc has recalled 82 units of its Insight Base Flex - 8 (Ref 608-3TX) because the patient label stickers may show an incorrect expiration date. A manufacturing error resulted in the manufacturing date (April 1, 2024) being printed as the expiration date, even though the product is actually safe to use until April 1, 2027. The correct expiration date is properly listed on the carton and sterile pouch labels. No incidents or injuries have been reported.
The error on the patient label stickers could lead medical staff to believe the device is expired when it is actually still within its sterile shelf life. While the risk of harm is low, accurate labeling is necessary for proper surgical inventory management and to ensure product integrity.
The error involves the manufacturing date (2024-04-01) being incorrectly listed as the expiration date on patient labels.
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Sources: FDA iRES · Raw API Response
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