China NMPA Product Recall - Disposable coronary artery injector

The National Medical Products Administration (NMPA) issued a recall event report on September 30, 2010, regarding disposable coronary artery injectors manufactured by Merit Medical System, Inc. The recall, managed in China by Merit Medical Devices (Beijing) Co., Ltd., pertained to six batches of various models, including CCS100 and CCS600. The primary issue identified was the potential for pores in the product packaging, which compromised the sterility of the injectors. This defect presented a significant patient risk, specifically the potential for infection, including sepsis, during clinical use for contrast solution injection in coronary angiography. Although no patient injuries or adverse events were reported, the voluntary recall was initiated to mitigate these serious health risks. Under the regulatory framework of the NMPA (formerly SFDA), Merit Medical Devices (Beijing) took prompt corrective actions. These included notifying all affected customers via email, express delivery, and fax, and subsequently recalling all affected products. All required actions were slated for completion by September 30, 2010, underscoring a rapid response to ensure product safety.