China NMPA Product Recall - Medical adhesive

Yongcheng City Science and Technology Experimental Factory initiated a voluntary Level 3 recall of its Medical Adhesive products following a surprise inspection by the National Medical Products Administration (NMPA) in 2020. The NMPA's inspection findings, detailed in Announcement No. 53 of 2020, prompted the Henan Provincial Drug Administration to mandate a comprehensive safety risk assessment for the company’s medical adhesive. The company identified issues, including considerations related to product upgrades, leading to potential safety hazards. Consequently, Yongcheng City Science and Technology Experimental Factory voluntarily recalled 21 batches of Medical Adhesive, totaling 32,340 tubes, all produced in 2020. The recall, reported on September 27, 2020, involved products registered under code 20173650254, intended for sealing surgical incisions. Required actions included establishing an internal recall team and commissioning third-party testing. A preliminary risk assessment indicated a low risk, with no reported harm to human health associated with the affected products. The company committed to recalling all identified batches to ensure medical device safety.