China NMPA Product Recall - Arterial blood collection device

BD Medical Devices (Shanghai) Co., Ltd., a subsidiary of Becton Dickinson and Company, initiated a voluntary Level II recall of specific Arterial Blood Collection Devices, as published by the National Medical Products Administration (NMPA) on April 6, 2017. The recall, stemming from a report dated February 21, 2017, affects 2,569,200 units globally, identified under National Medical Device Registration Certificate No. 20153150005. The primary issue is that the protective cover on these devices may not fully lock, despite users hearing a 'click' sound. This creates a potential safety concern as the device may not be securely activated. To address this, the company has outlined several required actions. Users are informed that the product can continue to be used, but they must visually confirm that the safety device is fully locked, in addition to listening for the 'click' sound. Furthermore, BD Medical Devices (Shanghai) Co., Ltd. is proactively sending written customer letters to inform all affected users about the incident and is developing a comprehensive user manual for the safety equipment to ensure correct daily usage.