China NMPA Product Recall - Temporary cardiac pacing lead

Ethicon, LLC initiated a voluntary Class III recall of its Temporary Cardiac Pacing Leads (Model TPW30, Batch JHH234), which was reported to China's National Medical Products Administration (NMPA) by its agent, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. The recall, with a report date of April 25, 2019, stemmed from issues identified in Russia by the Russian Ministry of Health and Social Development (RZN). The main violations included discrepancies between the product's Russian labeling and local regulatory requirements. Additionally, inconsistencies were found between Russian national standards and Ethicon’s internal testing methods, leading to deviations in product thickness measurement results. As no affected products were imported into China, the regulatory framework in China required Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. only to report the overseas event for NMPA's awareness and impact assessment. No further corrective actions, investigations, or follow-up reports are mandated or will be undertaken within China, as the recall's scope was strictly overseas.