China NMPA Product Recall - Arterial blood collection device

BD Medical Devices (Shanghai) Co., Ltd., representing Becton Dickinson and Company, initiated a voluntary Level II recall for specific batches of its BD Preset™ Arterial Blood Collection Devices, as announced by the National Medical Products Administration (NMPA) on March 17, 2017. The recall stemmed from user reports, mainly in North America, detailing instances where the protective cover on the device might not fully lock, despite an audible 'click' sound. This could lead to users mistakenly believing the safety mechanism is fully engaged. The recall impacts various models and specifications of the BD Preset™ 3ml Arterial Blood Collection Device with 22G, 23G, and 25G Eclipse™ Needles, with 2,569,200 units produced globally and 2,060,900 units sold in China. Corrective actions include informing users that the product can continue to be used, but they must visually confirm the complete locking of the safety device after hearing the click. Additionally, BD Medical Devices committed to sending written customer letters and producing an updated safety equipment user manual to provide clear usage instructions.