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

The National Medical Products Administration (NMPA) issued a notice on November 28, 2017, concerning a voluntary product recall initiated by Smiths Medical ASD, Inc. This recall involves CADD® infusion cartridges, which were distributed in China by Smith Medical Devices (Beijing) Co., Ltd. The core issue identified stemmed from the manufacturing process, specifically the use of an incorrect pressure plate during the production of these infusion cartridges. This manufacturing defect presents a critical safety concern, as it has the potential to cause partial or complete occlusion of the infusion tubing. Such an obstruction could lead to insufficient medication delivery to patients, thereby compromising treatment efficacy and patient safety. Smiths Medical ASD, Inc. is executing this voluntary recall under the regulatory framework indicated by the product's registration certificate (CFDA<Imported>20143543474). While specific inspection dates were not detailed, the NMPA's publication confirms the regulatory body's awareness and oversight of this action. The required action involves the comprehensive withdrawal of all affected CADD® infusion cartridges from the market to mitigate potential risks and ensure patient well-being.