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

Nanning Kelun New Technology Co., Ltd. initiated a voluntary Class III recall for its Multifunctional Electro-Ion Surgical Therapy Instrument (Registration Certificate No.: Gui Shi Yao Jian Xie (Zhun) Zi 2013 No. 2260008). The National Medical Products Administration (NMPA) publicly announced this recall on March 28, 2019, based on the company's report dated January 14, 2019. The primary issue was a label printing error; specifically, the product label lacked crucial information regarding power connection conditions, deviating from both regulatory and company standards. This recall impacts 10 units of the GX-III model from batch number E161210, all sold within China. As a Class III medical device, such labeling inaccuracies are critical under NMPA oversight. The required actions for Nanning Kelun New Technology Co., Ltd. include reprinting new labels that align with the registration certificate and company standards, and subsequently notifying all affected users to replace the incorrect labels on their devices, ensuring regulatory compliance and user safety.