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

Smiths Medical ASD, Inc., in collaboration with Smith Medical Devices (Beijing) Co., Ltd., initiated a voluntary recall of its CADD® brand infusion cartridges. This action, publicly announced by the National Medical Products Administration (NMPA) on November 28, 2017, addresses a critical manufacturing defect. The issue stems from the use of an incorrect pressure plate during the production process of these infusion cartridges. This manufacturing flaw poses a significant risk as it can lead to partial or complete occlusion of the infusion tubing, potentially resulting in insufficient medication delivery to patients. The regulatory framework for this recall is under the NMPA's oversight, with the document indexed as JGXX-2017-11142. As a required action, Smiths Medical ASD, Inc. is voluntarily recalling the affected infusion cartridges, identified by Registration Certificate No.: CFDA(Imported)20143543474, to ensure patient safety and address the potential health risks associated with the defective product.