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

Smiths Medical ASD, Inc. initiated a global Class I voluntary recall for its CADD infusion cartridges, as reported to the National Medical Products Administration (NMPA) on November 29, 2017, and published on November 30, 2017. The company’s agent in China is Smith Medical Devices (Beijing) Co., Ltd. The core issue driving this recall is a manufacturing defect involving an incorrect pressure plate within the infusion cartridge. This flaw can lead to partial or complete blockage of the infusion tubing, potentially causing insufficient or interrupted medication delivery to patients. One serious injury worldwide has been attributed to this malfunction. Under the regulatory guidance of the NMPA, Smiths Medical ASD, Inc. is required to undertake several actions. These include promptly dispatching emergency recall notices to all distributors, instructing them to inform their customers and retrieve all affected products. Subsequently, all recalled infusion cartridges are mandated for secure processing and destruction through Stericycle. The company clarified that the specific models and batches subject to this recall, identified as 21-7001-24 and 21-7100-24, were not sold in the Chinese market, negating the need for local corrective measures. Nevertheless, Chinese provincial food and drug administrations have been requested to reinforce their management and oversight concerning this recall event.