China NMPA Product Recall - Disposable suction catheter

Qingdao Shiyun Medical Equipment Co., Ltd. initiated a voluntary Class III recall for its Disposable Suction Catheter (Batch No.: 190304) on November 8, 2019, as reported to the National Medical Products Administration (NMPA) on December 20, 2019. This action followed national medical device quality spot checks that identified non-compliance with the mandatory standard YY0339-2009. Specifically, certain aspects of the product, identified as Type II 12FR, did not meet the required specifications outlined in this standard, which governs the safety and performance of such medical devices. The recall affects 3,512 manufactured units, with 3,500 units having been distributed within China. In response to the identified quality deviation, Qingdao Shiyun Medical Equipment Co., Ltd. is undertaking several corrective measures. These include compiling comprehensive sales data for the affected batch and actively assisting in the retrieval of all unused products from the market. Furthermore, distributors have been notified and instructed to immediately cease the sale and use of the recalled batch of disposable suction catheters, with all retrieved items to be returned to the manufacturer. This recall underscores the company's commitment to product safety and adherence to national regulatory standards.