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

Smiths Medical ASD, Inc., represented by its Chinese agent Smith Medical Devices (Beijing) Co., Ltd., initiated a Class I voluntary recall of its CADD reservoir cartridges. This recall, published by the National Medical Products Administration (NMPA) on December 4, 2017, addressed a critical manufacturing defect. An incorrect pressure plate used during production could cause partial or complete blockage of the infusion tube, potentially leading to insufficient medication delivery to patients. While Smiths Medical received reports of serious injuries globally due to this issue, no patient harm was reported within China. Under the NMPA’s regulatory oversight, the required actions included issuing emergency recall notices to distributors to inform customers and retrieve affected products. All recalled units were slated for processing and destruction by Stericycle. Significantly, Smith Medical Devices (Beijing) Co., Ltd. confirmed that the specific product models (21-7001-24 and 21-7100-24) identified with the defect were not distributed in China. Therefore, no direct corrective actions were necessary for these particular specifications within the Chinese market, with the NMPA notice serving to inform stakeholders about the global recall.