China NMPA Product Recall - Disposable human venous blood collection container

Liuyang Sanli Medical Technology Development Co., Ltd. initiated a Class III voluntary recall of its Disposable Human Venous Blood Sample Collection Containers under the oversight of China's National Medical Products Administration (NMPA). The recall, reported on September 1 and 16, 2020, and publicly announced on September 21, 2020, addresses a critical quality deficiency: insufficient purity of additives in the product tubes. This issue, affecting specific batches such as 181004, 191002, and 191211 of Sodium Citrate 9:1 2ml containers, led to blood clotting after sample collection, rendering the devices unsuitable for their intended use in medical laboratories. The recall impacts significant quantities, including 860,000 units in Liaoning Province, 720,000 units in Inner Mongolia and Guizhou Province, and 360,000 units in Hunan Province. As required actions, the company established a recall leadership team, with the Marketing Department tasked with notifying distributors and users via multiple communication channels. Recalled products are managed in a dedicated warehouse, with unfit items subject to destruction under drug regulatory authority supervision. Products approved after quality evaluation and regulatory consent may be reintroduced.