China NMPA Product Recall - Three-way valve for intravenous infusion

Becton Dickinson Infusion Therapy AB, in conjunction with its Shanghai affiliate, Becton Dickinson Medical Devices (Shanghai) Co., Ltd., has initiated a voluntary Class II recall for its infusion three-way stoppers. This action, publicly reported by the National Medical Products Administration (NMPA) on June 21, 2019, stems from a critical quality concern: potential contamination detected within the sealed packaging of the medical devices. The specific product under recall is identified by Registration Certificate No. 20153660239. The primary issue is the risk of compromised sterility, which could potentially affect patient safety and treatment efficacy. While the provided document is a recall announcement and does not detail specific inspection dates, it highlights the company's proactive measure to address identified quality control deficiencies. The regulatory framework for this recall is established by the NMPA, which oversees medical device safety standards in China. Required actions involve the comprehensive removal of all affected product batches from the market. Detailed information concerning the specific models, specifications, and batch numbers of the recalled products is contained within the 'Medical Device Recall Event Report Form' attachment, ensuring thorough accountability and compliance with regulatory directives.