China NMPA Product Recall - Activated Coagulation Time Assay Kit (Coagulation Method) HR-ACT Cartridge

Medtronic Inc., through its subsidiary Medtronic (Shanghai) Management Co., Ltd., has initiated a voluntary Level II recall for its Activated Coagulation Time Assay Kit (Clotting Method) HR-ACT Cartridge. The recall was prompted by the discovery of bloodstains on the outer carton label and instruction manual of five boxes from a specific batch of the product at Medtronic Global. This issue was identified internally by Medtronic (Shanghai) Management Co., Ltd. and subsequently reported to the National Medical Products Administration (NMPA).

While no complaints or adverse events related to these specific contaminated products have been reported to date, the company is proactively recalling the affected kits to uphold product integrity and ensure patient safety. This action aligns with the regulatory framework set by the NMPA, with the affected product holding Medical Device Registration Certificate No. 20172401652. The required action involves the voluntary removal of the impacted products from the market. Further specific details regarding models, specifications, and batch numbers are provided in the comprehensive "Medical Device Recall Event Report Form" attached to the public notice. This recall highlights Medtronic's commitment to quality control and compliance under regulatory oversight.