China NMPA Product Recall - Disposable suction catheter

Shanghai Honglong Medical Supplies Equipment Co., Ltd. initiated a voluntary Class III recall of its disposable suction catheters, as announced on July 1, 2019, by the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration (SFDA) under recall number 2019-151. The recall stems from a quality control issue identified during a random inspection, which revealed that certain batches of the disposable suction catheters failed to meet the specified minimum inner diameter requirement for the product's head. This non-conformance with product specifications prompted the company to take immediate corrective action. The regulatory framework overseeing this event involves both the national NMPA and the local SFDA, which facilitate the recall process to ensure product safety and compliance. As a required action, Shanghai Honglong Medical Supplies Equipment Co., Ltd. is recalling all affected products, with detailed information on specific models, specifications, and batch numbers available in the attached Medical Device Recall Event Report Form. This action underscores the company's commitment to product quality and patient safety, addressing a critical manufacturing deviation.