China NMPA Product Recall - Multifunctional Electro-ion Surgical Therapy Instrument

Nanning Kelun New Technology Co., Ltd. initiated a voluntary Class III medical device recall, reported on January 14, 2019, and published by the National Medical Products Administration (NMPA) on January 23, 2019. The recall concerns their Multifunctional Electro-Ion Surgical Therapy Instrument, registered under certificate number Gui Shi Yao Jian Xie (Zhun) Zi 2013 No. 2260008. The primary issue identified was label printing errors, specifically the omission of crucial information regarding power connection conditions on the product's label. This recall affected a single batch, E161210, comprising 10 units of the GX-III model, all of which had been sold within China. The instrument is intended for various medical applications, including dermatology, surgery, and cosmetology. Under the NMPA's regulatory framework, a Class III recall indicates a situation where use of or exposure to a violative product is not likely to cause adverse health consequences. To rectify the non-compliance, Nanning Kelun New Technology Co., Ltd. is required to reprint labels that accurately reflect the product's registration certificate and company standards. Additionally, the company must notify all users to ensure the replacement of the erroneous labels with the correct versions. This action aims to ensure product information accuracy and compliance with regulatory requirements.