China NMPA Product Recall - Laparoscopic surgical instruments

On July 28, 2017, the National Medical Products Administration (NMPA) processed a Medical Device Recall Event Report concerning laparoscopic surgical instruments manufactured by MICROLINE SURGICAL INC., with Tianjin Qingsong Huayao Pharmaceutical Co., Ltd. acting as the agent in China. This global Level 3 recall was initiated due to a potential safety issue with the insulating layer on the repetitive manipulation heads (grasping and dissecting forceps) of these instruments. The black heat-shrink material used for insulation presented a risk of cracking after high-temperature, high-pressure sterilization or re-sterilization. While the manufacturer, Microline, confirmed no patient harm reports had been received, the recall was proactively enacted to prevent potential risks during surgical procedures. The recall in China affects 70 imported batches, totaling 2245 units across various models and specifications, identified by specific product codes. Required actions include issuing recall notices to all domestic customers, obtaining confirmation receipts, and returning all affected products to the manufacturer for appropriate processing, ensuring adherence to regulatory standards and patient safety.