Becton dickinson medical devices (shanghai) co., ltd. initiates voluntary recall of infusion three-way stopcocks and partition membrane sealed three-way stopcocks

BD Medical Devices (Shanghai) Co., Ltd. Voluntarily Recalls Three-Way Stopcocks for Infusion Use; Septum Closed Three-Way Stopcocks

Shanghai Medical Device Regulatory Authority Primary Recall 2026-091

Becton Dickinson Medical Devices (Shanghai) Co., Ltd. reported that Becton Dickinson Switzerland discovered through customer feedback that there are operational issues with the C port of specific batches of membrane-sealed three-way stopcocks/infusion three-way stopcocks during use. Customer feedback indicates that when connecting to polypropylene luer lock syringes, the C port may experience excessive screwing and continuous spinning during the connection process, leading some clinical users to believe that the connection stability is insufficient. Testing by Becton Dickinson Switzerland showed that under clinical simulation conditions related to this issue, the connection remains reliable, and no leakage risk was found. Additionally, tests confirmed that when connecting the C port to polycarbonate syringes or infusion line luer connectors, the aforementioned phenomenon does not occur. Further testing revealed that when using polypropylene syringes, the required connection torque at the C port is relatively low, making it easier to bypass the syringe thread position, thus creating an apparent excessive screwing phenomenon. This observation aligns with customer feedback. The torque differences during the connection process and the resulting excessive screwing phenomenon may cause confusion among users during product use. By following the current operating instructions, potential usage risks can be effectively minimized. This recall aims to reinforce important usage recommendations when using membrane-sealed three-way stopcocks/infusion three-way stopcocks. Becton Dickinson Medical Devices (Shanghai) Co., Ltd. is proactively recalling its infusion three-way stopcocks and membrane-sealed three-way stopcocks (registration certificate numbers: National Medical Device Registration No. 20153140239; National Medical Device Registration No. 20173140382). The recall level is classified as Class II.