China NMPA Product Recall - SURGICEL Abs Hemostat Absorbable Hemostatic Gauze

The National Medical Products Administration (NMPA) issued an announcement on June 27, 2024, regarding a Class II voluntary recall initiated by Ethicon LLC. This recall pertains to their absorbable hemostatic gauze, SURGICEL Abs Hemostat, which holds National Medical Device Registration Certificate No. 20153141908. Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. reported the recall on behalf of the manufacturer. The core issue driving this action is damage observed in the sterile barrier of the primary packaging for certain product batches. Such damage compromises the sterility of the medical device, potentially posing a risk to patient safety during use. Ethicon LLC is taking proactive measures to address these packaging integrity concerns. A significant detail confirmed in the NMPA document is that the specific products identified in this recall were not imported into the Chinese market. Detailed information concerning the affected models, specifications, and batch numbers is accessible through the provided "Medical Device Recall Table" and "Medical Device Recall Event Report Form." This NMPA notice highlights ongoing regulatory vigilance over medical device quality and safety.