Smiths Medical identified a labeling error in which the barcode (UDI) was not correctly reflecting the expiration date of the product. Specifically, an additional 3 years was added to the expiration date within the udi barcode of the label. The identified incorrect expiration date in the UDI barcode could result in the use of impacted devices beyond the actual expiration date of the product. The clinical impact of this mislabeling is delay of therapy due to confusion of the expiration date that is listed in the barcode compared to that written on the label. Additionally, the potential for the use of a product longer than indicated with the potential for degraded functionality was identified in the circumstance that the user scans the barcode for expiration tracking and/or explicitly confirms the expiration of the product with the UDI barcode. Recall Start Date: July 13, 2023
RecallTracker