China NMPA Product Recall - Disposable vacuum venous blood collection container

BD Medical Devices (Shanghai) Co., Ltd., representing manufacturer Becton Dickinson and Company, initiated a voluntary Class III recall of its Disposable Vacuum Venous Blood Sample Collection Containers. This action, reported to the National Medical Products Administration (NMPA) on December 15, 2015, stemmed from complaints by overseas customers. The primary issue involved rubber stoppers detaching from or being squeezed out of the blood collection tube during use, posing a risk of blood exposure and sample loss. The affected products, identified by Item Number 367856 and Batch Number 5014806, were manufactured in a quantity of 170,000 units and distributed across regions including the USA, Canada, and South Korea. Under the NMPA's regulatory guidance, the company's required actions included the destruction of all affected sealed batches. Notably, none of the recalled products were sold within China, negating the need for customer returns in the domestic market. This recall underscores the company's commitment to product safety and quality assurance.