China NMPA Product Recall - Drug infusion system

On June 19, 2017, the National Medical Products Administration (NMPA) announced a voluntary Class I recall initiated by Medtronic (Shanghai) Management Co., Ltd. for its drug infusion systems. This significant action was taken due to a critical safety concern: the affected products experienced deterioration in battery performance, which directly posed a risk to patient safety. The recall, indexed as JGXX-2017-10484, pertains specifically to drug infusion systems with Registration No.: CFDA Registration No. 3545542. A Class I recall designation signifies the most serious type of recall, indicating that there is a reasonable probability that using or being exposed to a violative product will cause serious adverse health consequences or death. Medtronic (Shanghai) Management Co., Ltd. proactively reported this issue, leading to the recall to mitigate potential harm. The company is required to provide detailed information regarding the specific models, specifications, and batches of the affected devices in a 'Medical Device Recall Event Report Form.' This measure underscores the NMPA's commitment to overseeing medical device safety and ensuring that companies address product deficiencies promptly and effectively to protect public health.