China NMPA Product Recall - Single-use sterile injection needles; single-use sterile syringes with needles

BD Medical Devices (Shanghai) Co., Ltd., a subsidiary of Becton Dickinson and Company, initiated a Level I voluntary recall for specific batches of its disposable sterile injection needles and disposable sterile syringes with needles. This recall was publicly announced by the National Medical Products Administration (NMPA) on February 21, 2017, following the company's internal report dated December 29, 2016. The primary issue prompting this action is the potential for the protective shield on these devices to detach when activated, exposing the needle and significantly increasing the risk of needlestick injuries. Customer reports, primarily from North America, indicated that a preliminary "click" sound during activation might not signify a fully locked protective shield. While no complaints or adverse events related to this specific issue were reported in China, the company's corrective actions include advising customers that products can continue to be used, provided users strictly adhere to the instructions for use. Specifically, users must ensure the protective shield is fully engaged immediately after injection and that the needle tip is completely covered. BD Medical Devices also committed to proactively sending written customer letters to inform them of the incident, emphasizing proper usage protocols.