China NMPA Product Recall - Fluid Warming System

On September 28, 2021, Smith Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its Fluid Warming System (Registration Certificate No.: 20152141776). This action was taken in response to a potential product issue where aluminum ions might seep into the heating fluid under specific usage conditions. The National Medical Products Administration (NMPA) published this recall, identified by Index No. JGXX-2021-10524. The company's decision to conduct a voluntary recall underscores its commitment to product safety and compliance with regulatory standards overseen by the NMPA. A Class III recall indicates that the use of or exposure to the affected product is not likely to cause adverse health consequences, but it mandates that the company address the identified issue to ensure ongoing product integrity and patient safety. Smith Medical Devices (Shanghai) Co., Ltd. has advised that comprehensive details regarding the specific models, specifications, and batch numbers of the affected Fluid Warming Systems are available in a dedicated "Medical Device Recall Event Report Form," which stakeholders are encouraged to consult for further information and guidance on required actions. This recall ensures that potential risks associated with the device are proactively managed.