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

On November 28, 2017, Smiths Medical ASD, Inc., in cooperation with its Chinese subsidiary Smith Medical Devices (Beijing) Co., Ltd., issued a voluntary Class I global recall for its CADD R infusion cartridges, specifically Model 21-7002-24. This action was reported to and overseen by the National Medical Products Administration (NMPA). The primary issue identified was a manufacturing defect where an incorrect pressure plate was used in the production of these liquid reservoir devices. This critical flaw can result in the partial or complete blockage of the infusion tubing, which could lead to a severe consequence of insufficient medication administration to patients. While one serious injury globally has been attributed to this issue, no related patient harm reports have been received within China. A substantial volume of 331,890 affected units of this medical device were distributed and sold in China. To address the safety concern, required actions included issuing immediate emergency recall notices to all distributors. These notices mandated that distributors inform their customers and facilitate the prompt retrieval of all affected products. Subsequently, all recalled infusion cartridges are to be submitted to Stericycle for appropriate processing and disposal, ensuring removal from circulation and upholding patient safety standards.