China NMPA Product Recall - Disposable sterile surgical gown

Yu'an Medical Technology Development Co., Ltd. initiated a voluntary Level III recall for a batch (18080118) of its Disposable Sterile Surgical Gowns. The recall was reported on July 18, 2019, and publicly announced by the National Medical Products Administration (NMPA) on October 11, 2019. This action followed a national medical device supervision and spot check by the Shandong Provincial Medical Device Product Quality Inspection Center, which found the product to be non-compliant with technical requirements. Specifically, the burst strength and tensile strength of the sleeves, a critical area, did not meet the specified standards for both dry and wet states. Approximately 300 affected units were distributed in regions such as Jinzhong City, Shanxi Province. In response, Yu'an Medical Technology Development Co., Ltd. recalled the products already sold, ensuring effective treatment of the batch. The company subsequently performed a root cause analysis, implemented corrective measures, and established preventative actions to ensure ongoing compliance with NMPA's medical device quality and safety regulations.