China NMPA Product Recall - Liquid reservoir (trade name: CADD)

On November 30, 2017, the National Medical Products Administration (NMPA) announced a Class I voluntary recall initiated by Smiths Medical ASD, Inc. concerning its CADD infusion cartridges. This critical recall addresses a manufacturing defect where an incorrect pressure plate was utilized during production. This error presents a significant risk, as it may cause partial or complete blockage of the infusion tubing, potentially leading to insufficient or absent medication delivery to patients. Smiths Medical ASD, Inc., the manufacturer, in conjunction with its distributor, Smith Medical Devices (Beijing) Co., Ltd., is managing this recall. The NMPA's Class I designation underscores the serious health consequences that could arise from using the affected product. Importantly, the manufacturer has confirmed that the recalled batches of CADD infusion cartridges were not distributed or sold within the Chinese market. In response to this international recall, the NMPA has instructed all provincial, autonomous regional, and municipal Food and Drug Administrations to enhance their oversight and management of this specific product matter, ensuring continued vigilance in medical device safety.