China NMPA Product Recall - Disposable medical laryngeal mask

Jiangsu Lifeng Biotechnology Co., Ltd. has initiated a voluntary Level III recall of its disposable medical laryngeal masks, specifically Model Classic 3.0#, Production Batch 22032801. This action follows a discovery made during a 2022 Jiangsu Provincial Medical Device Supervision and Inspection, which identified connector defects. The main issue was that the connector's tip did not meet standard dimensional requirements, failing to be correctly positioned on the step between the minimum and maximum diameters of the gauge, as mandated by standard YY1040.1-2015. The regulatory framework for this recall is provided by the National Medical Products Administration (NMPA) and the Jiangsu Provincial Drug Administration. Of the 500 units produced, 350 were distributed nationwide. Required actions include immediately stopping sales of the affected batch and notifying distributors to facilitate the recall. Additionally, Jiangsu Lifeng Biotechnology Co., Ltd. committed to improving quality control by adding a 15mm ring gauge to procurement standards and updating its inspection procedures to measure connector dimensions using a standard 15mm ring gauge, ensuring compliance with industry standards. No adverse events related to the defect were reported.