China NMPA Product Recall - High-frequency electrosurgical system accessories

Covidien LLC, with its agent Covidien Medical Devices International Trading (Shanghai) Co., Ltd., initiated a voluntary Class II recall of accessories for its high-frequency electrosurgical system (NMPA Registration Certificate No. 20163251111). The recall was reported on March 8, 2019, and subsequently published by the National Medical Products Administration (NMPA) on March 18, 2019. The main issue prompting this action was the identified potential for incomplete sealing in the sterile packaging of specific batches of these accessories. This defect could compromise product sterility, thereby increasing the risk of infection for patients during surgical procedures. The affected product model is FT3000, with identified batch numbers like 80390309X. Under the regulatory framework communicated by the NMPA, the company took proactive steps to address this manufacturing concern. Notably, Covidien LLC confirmed that no affected products were sold within China, meaning no further corrective actions were required in that region. The company reported no complaints related to this issue globally at the time of the recall, highlighting a proactive approach to product safety and regulatory compliance.