China NMPA Product Recall - Pre-filled Flushing Syringes (BD Pre-filled Flush Syringes)

Becton, Dickinson and Company initiated a voluntary Class III recall of its pre-filled BD Pre-filled Flush Syringes. The recall, reported by Becton Medical Devices (Shanghai) Co., Ltd. on December 5, 2023, addresses a critical issue involving the use of an incorrect piston within these medical devices. The affected products are registered under National Medical Device Registration Certificate No. 20163142809. This action falls under the regulatory oversight of the National Medical Products Administration (NMPA), ensuring compliance with established medical device safety standards in China. The primary concern is the potential impact on product performance and patient safety due to the identified manufacturing discrepancy. While specific inspection dates are not detailed, the recall announcement itself serves as a regulatory notice. Detailed information regarding the specific models, specifications, and batch numbers involved in this recall are provided in an accompanying "Medical Device Recall Event Report Form," indicating the company's adherence to required reporting protocols for such events.