China NMPA Product Recall - Traditional Chinese Medicine Moxibustion Equipment

Hunan Cihui Medical Technology Co., Ltd. initiated a voluntary Class III recall for its Traditional Chinese Medicine Moxibustion Devices, specifically the Thunder-Fire and Lamp-Fire Moxibustion types. The recall, reported on September 15, 2020, was prompted by two significant issues: the company's production and sale of unregistered Class II medical devices, and the lamp-fire moxibustion device's composition not meeting its registered product technical requirements. Under the regulatory framework of the National Medical Products Administration (NMPA) and the Hunan Provincial Drug Administration, the company identified multiple affected batches (including 20050515, 19110402, 19102001, 20051501), impacting numerous boxes sold primarily in Changsha City, Hunan Province. Required actions include establishing a dedicated Product Recall Leadership Team and tasking the Quality Department with disseminating recall information to all distributors via telephone, fax, and email. Furthermore, all recalled products must be stored in a dedicated warehouse. Following a quality evaluation, products slated for destruction will be disposed of under the strict supervision of the drug regulatory authority. Conversely, any products deemed acceptable for sale after evaluation will only re-enter the market with explicit approval from the drug regulatory authority.