China NMPA Product Recall - Disposable sterile injection needles

On November 22, 2020, the National Medical Products Administration (NMPA) announced a voluntary Level II recall initiated by BD Medical Devices (Shanghai) Co., Ltd. This action pertains to specific batches of disposable sterile injection needles, identified under Registration Certificate No.: 国械注进20183151766. The recall stems from BD's internal discovery that some of these medical devices may be contaminated, posing a potential risk of infection if used without prior detection of the contamination. The recall is conducted under the regulatory oversight of the NMPA and the Shanghai Municipal Drug Administration. A Level II recall indicates that the product may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. BD Medical Devices (Shanghai) Co., Ltd. is taking proactive steps to remove the affected products from circulation. Further details on the specific models, specifications, and batch numbers of the recalled needles are available in the "Medical Device Recall Event Report Form" provided by the company, facilitating the identification and management of affected inventory. This voluntary measure emphasizes the manufacturer's commitment to ensuring product safety and compliance within the medical device sector.