China NMPA Product Recall - Calcium alginate dressing

Smith & Nephew Medical Ltd, a UK-based manufacturer, initiated a voluntary Class III recall for specific batches of its Calcium Alginate Dressings. This action was reported to the National Medical Products Administration (NMPA) on April 9, 2019, with the official recall notice published on April 19, 2019. The main issue prompting the recall was the inconsistency between the product's registered shelf life, sterilization method, and instructions for use, as recorded with the Russian Federal Service for Supervision of Public Health and Social Development, and the actual product information. This discrepancy affected product models 66000519, 66000520, 66000521, and 66000522. The recall specifically targeted products distributed in Russia and the Union State of Russia. Importantly, the document clarifies that this recall does not affect the Chinese market, with no affected products sold in China. As a voluntary measure, Smith & Nephew is responsible for implementing corrective actions in the identified regions under the NMPA's regulatory oversight to resolve these informational discrepancies.