China NMPA Product Recall - Injection pump

Shenzhen Haoke Medical Instrument Co., Ltd. voluntarily initiated a Level III recall for a batch of its injection pumps (model HK-400, batch number 201901006). This recall, overseen by the National Medical Products Administration (NMPA) of China, was formally published on September 12, 2019, based on a recall event report dated September 6, 2017. The primary issue identified was a software version burning error during manufacturing, affecting 20 units, with 9 specific serial numbers sold in China. This error led to a critical non-compliance: pressing the alarm deactivation button on affected devices incorrectly cleared some alarms, failing to meet the product's technical specifications. As of the report date, no adverse events related to this deficiency had been reported. To rectify the issue, Shenzhen Haoke Medical Instrument Co., Ltd. committed to two corrective actions. Firstly, the company is sending formal notification letters to all affected customers to inform them of the recall and its implications. Secondly, Shenzhen Haoke will directly contact these customers to facilitate a necessary software upgrade for their injection pumps, ensuring the devices function according to their intended technical requirements and specifications. This action aims to restore the safety and efficacy of the recalled medical devices.