China NMPA Product Recall - Abdominal trocar

Hangzhou Tonglu Yida Medical Device Equipment Co., Ltd. initiated a voluntary Class III recall of its Abdominal Puncture Devices (Registration Certificate No.: Zhexiezhuzhun 20172220107), as announced by the National Medical Products Administration (NMPA) on January 17, 2019. The recall stemmed from a non-compliance identified during a national medical device supervision and spot check. The main issue was that the product failed to meet the specified standard for the maximum mating clearance between the puncture cannula and the puncture needle, which should not exceed 0.3mm. The affected products belong to model YDCC/5.5 × 95, batch number 18051710. A total of 20 units were produced in this specific batch. The regulatory framework under which this issue was identified is the NMPA's national medical device supervision. As required actions, Hangzhou Tonglu Yida Medical Device Equipment Co., Ltd. verified the production quantity of the non-compliant batch. Importantly, all 20 units from this batch were subject to state sampling and, consequently, none of them entered the market or were sold to consumers. The non-compliant samples were not returned to the manufacturer but were instead destroyed by the Shanghai Medical Device Inspection Institute, ensuring public safety and preventing distribution of the defective devices.