China NMPA Product Recall - Disposable high-flow-rate Normothermic I.V. Fluid Administration Set and Accessories

Smiths Medical ASD, INC., in collaboration with Smith Medical Devices (Shanghai) Co., Ltd., has initiated a voluntary Class II recall for its single-use high-flow temperature fluid tubing and accessories, specifically the Normothermic I.V. Fluid Administration Set and Accessories. This recall, announced by the National Medical Products Administration (NMPA) on November 13, 2024, addresses a significant issue where users reported an inability to correctly install the products. This installation difficulty could potentially impair the intended function and safety of the medical devices, which are registered under National Medical Device Registration Certificate No. 20163141672. While specific batch details are outlined in an accompanying recall report form, the NMPA confirmed that the implicated products were not imported into the Chinese market. The Class II classification signifies that the use of, or exposure to, the affected product might lead to temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. This proactive measure by Smiths Medical ASD, INC. demonstrates its commitment to product quality and patient safety under the NMPA's regulatory oversight, even for devices distributed internationally.