China NMPA Product Recall - Laparoscopic surgical instruments

On July 28, 2017, the National Medical Products Administration (NMPA) issued a Medical Device Recall Event Report concerning Laparoscopic Surgical Instruments manufactured by MICROLINE SURGICAL INC. The recall was initiated by the recalling unit, Tianjin Qingsong Huayao Pharmaceutical Co., Ltd. The primary issue identified was a potential risk where the insulating layer on the repetitive manipulation heads (grasping and dissecting forceps), made of black heat-shrink material, could crack after high-temperature, high-pressure sterilization or re-sterilization. Although no patient harm reports had been received, the manufacturer proactively initiated a global Level 3 recall to mitigate potential risks. This recall affects 70 imported batches, totaling 2245 units, with 849 units sold in China.

Operating under the NMPA's regulatory framework for medical device recalls, specific actions are required. The recalling unit is mandated to issue recall notices to all domestic customers and secure confirmation receipts for these communications. Additionally, all recalled products must be returned to MICROLINE SURGICAL INC for appropriate processing. This proactive measure underscores a commitment to patient safety by addressing potential device degradation risks post-sterilization.