China NMPA Product Recall - Wrist electronic blood pressure monitor

Shenzhen Bangpu Medical Equipment Systems Co., Ltd. initiated a voluntary Level 3 recall for its Wrist Electronic Blood Pressure Monitors, specifically model WF1610B from batch 1803024. This action, reported on November 7, 2018, and publicized by the National Medical Products Administration (NMPA) on December 4, 2018, stemmed from a medical device sampling inspection. The inspection revealed that the devices did not meet the required accuracy standards for their pressure sensors, indicating a critical quality control deficiency.

The recall encompassed 80 units of the affected batch, with 57 units already distributed to end-users in China. As part of the company's corrective strategy, Shenzhen Bangpu committed to identifying and retrieving all affected products using their unique batch numbers. Upon retrieval, the company plans to re-examine the devices to thoroughly investigate the underlying causes of the non-conformity. Subsequently, the manufacturer will implement comprehensive corrective and preventative measures to address the identified defects and ensure future product adherence to national medical device regulations, thereby reinforcing its commitment to product quality and safety.