China NMPA Product Recall - Arterial blood collection device

BD Medical Devices (Shanghai) Co., Ltd., the Chinese arm of manufacturer Becton Dickinson and Company, initiated a voluntary Level II recall of its Arterial Blood Collection Devices. This recall, reported on February 21, 2017, and subsequently published by the National Medical Products Administration (NMPA) on March 17, 2017, addressed a user safety concern regarding the device's protective cover. The core issue identified was that users might rely solely on an audible "click" sound to confirm the protective cover was locked, even when it was not fully secured. This oversight could potentially compromise the device's safety mechanism. While the product is deemed safe for continued use with proper precautions, BD Medical Devices (Shanghai) Co., Ltd. has taken corrective actions. These include proactively dispatching written customer letters to inform users of the incident and developing a specific user manual for the safety equipment. The company emphasizes to users that visual confirmation of the fully locked protective cover is essential, in addition to hearing the 'click' sound, to ensure proper device functionality and safety. The global recall impacts approximately 2.57 million units across various BD Preset™ 3ml Arterial Blood Collection Device models.