China NMPA Product Recall - Calcium alginate dressing

Smith & Nephew Medical Ltd, a UK-based manufacturer, initiated a voluntary Class III recall of its calcium alginate dressings (Registration Certificate No.: 20173646753) due to identified discrepancies. Reported by its agent, Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd., on April 9, 2019, and published by the National Medical Products Administration (NMPA) on April 22, 2019, the recall addresses critical inconsistencies. The primary issue involves a mismatch between the registered shelf life, sterilization method, and instructions for use information submitted to the Russian Federal Service for Supervision of Consumer Health and Social Development, and the actual product details. Affected product models include 66000519, 66000520, 66000521, and 66000522, impacting various batch numbers. While the recall specifically targets products sold in regions such as the Russian Federation, the document explicitly states that this recall does not affect the Chinese market, with zero reported product sales in China for the affected batches. The required action is a voluntary Class III recall to rectify these informational discrepancies.