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

On November 28, 2017, the National Medical Products Administration (NMPA) reported a voluntary Level 1 recall initiated by Smiths Medical ASD, Inc. concerning its CADD® infusion cartridges (Registration Certificate No.: CFDA<Imported>20143543474). The recall was prompted by a manufacturing defect where an incorrect pressure plate was used in certain CADD reservoirs. This error could lead to partial or complete occlusion of the infusion tubing, potentially resulting in insufficient medication delivery to patients.

Smiths Medical Devices (Beijing) Co., Ltd., the product's agent in China, assisted in reporting this critical issue. Globally, one serious injury related to this defect has been reported, though no patient harm in China was noted. The recall affects a significant quantity, with 331,890 units sold in China alone, as part of a broader global recall.

To address the issue, Smiths Medical initiated immediate corrective actions. These included issuing emergency recall notices to all distributors, instructing them to notify their customers and retrieve all affected products. Subsequently, all recalled infusion cartridges are to be submitted to Stericycle for proper processing and disposal, ensuring the removal of potentially faulty devices from the market. This action underscores the company's commitment to patient safety and adherence to regulatory standards under the NMPA framework.