China NMPA Product Recall - Chengdu Sibirui Technology Co., Ltd.

On September 27, 2021, Chengdu Sibirite Technology Co., Ltd. proactively initiated a voluntary recall of certain medical devices, as reported by the National Medical Products Administration (NMPA) and sourced from the Sichuan Provincial Drug Administration Website. This significant action was taken following an internal investigation and evaluation that revealed inherent product defects. Although specific details regarding the affected models, specifications, and batches are contained within an attached Medical Device Recall Event Report Form, the fundamental reason for the recall is the presence of these identified product deficiencies. This voluntary recall demonstrates the company's adherence to the NMPA's stringent regulatory framework governing medical device safety and quality in China. The NMPA's robust system requires manufacturers to take decisive steps, such as recalls, when product integrity is compromised. Consequently, Chengdu Sibirite Technology Co., Ltd.'s required action involves the immediate and comprehensive implementation of this voluntary recall to safeguard public health and ensure compliance with national medical device regulations, thereby addressing the discovered product issues effectively and responsibly.