China NMPA Product Recall - Surgical patch

On March 17, 2021, the National Medical Products Administration (NMPA) published notice of a voluntary Class II recall initiated by Sofradim Production concerning specific surgical patches. This recall was formally reported by Covidien Medical Devices International Trading (Shanghai) Co., Ltd. The core issue leading to this regulatory action was identified as a packaging error affecting particular models and batches of the medical devices. The recall, overseen by the NMPA, represents a required action by Sofradim Production to address a potential risk where use of the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote – fitting the Class II classification. While specific inspection dates were not detailed, the publication date marks the official announcement. Further comprehensive information, including the exact affected models, specifications, and batch numbers, is available in the "Medical Device Recall Event Report Form." This proactive measure highlights the company's adherence to regulatory standards and commitment to patient safety within the NMPA's framework.