China NMPA Product Recall - Tetracaine hydrochloride endoscope lubricant

The National Medical Products Administration (NMPA) announced on November 7, 2018, a voluntary Class III recall initiated by Fuzhou Xianya Biotechnology Co., Ltd. for its Tetracaine Hydrochloride Endoscopic Lubricant. This significant action was taken following a supervised sampling inspection that identified substandard quality in the product. The issue prompted the company to address the deficiency proactively, ensuring compliance with established regulatory standards for medical devices. The recall details, including specific product models, specifications, and batch numbers, are documented in the Medical Device Recall Event Report Form, dated October 12, 2018. The partial registration number for the affected product is 国械注准201. A Class III recall indicates that the use of, or exposure to, the violative product is not likely to cause adverse health consequences. Fuzhou Xianya Biotechnology Co., Ltd.'s prompt response under the NMPA's regulatory oversight highlights the importance of maintaining product quality and safety within the medical device industry.