China NMPA Product Recall - Disposable vacuum venous blood collection container

BD Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its disposable vacuum venous blood collection containers. Announced on October 11, 2017, by the National Medical Products Administration (NMPA), this action addresses a significant product quality issue. The company identified that certain batches of these containers, registered under No.: 20152413656, may contain insufficient anticoagulant. This deficiency presents a risk of occasional clotting phenomena during the blood collection process, which could compromise sample integrity and potentially impact diagnostic accuracy. Under the regulatory framework governed by the NMPA, the required action is a comprehensive voluntary recall of all affected units. BD Medical Devices (Shanghai) Co., Ltd. is providing detailed information, including specific models, specifications, and batch numbers of the affected products, in an attached "Medical Device Recall Event Report Form." This proactive measure aims to mitigate potential patient risks and uphold product quality standards.