China NMPA Product Recall - Disposable coronary artery syringe

The National Medical Products Administration (NMPA) published recall report JGXX-2010-10114 on November 3, 2010, regarding disposable coronary artery injectors. Merit Medical System, Inc., and its Chinese unit, Merit Medical Devices (Beijing) Co., Ltd., initiated a voluntary recall of six batches and models of these devices (e.g., CCS100 batch H137479, CCS600 batch H135352). The recall stemmed from the discovery that the product packaging might contain pores, compromising the sterility of the injectors. This defect posed a significant infection risk, potentially leading to sepsis, although no patient injuries or adverse events were reported.

Operating under the NMPA's medical device recall framework, Merit Medical Devices (Beijing) Co., Ltd. implemented specific corrective actions. These involved promptly notifying customers, identified through shipping records, via various communication channels. The recall of affected products was completed by September 30, 2010. Verification with distributors confirmed that 8187 of 8300 affected products had been utilized, while the remaining 113 units were successfully returned to the company for destruction, thereby mitigating potential health risks associated with the non-sterile devices.