China NMPA Product Recall - Disposable human venous blood collection container

Hebi Zhongxing Medical Supplies Co., Ltd. initiated a voluntary Level III recall of its disposable human venous blood sampling containers. This action, published on July 6, 2017, was prompted by the company's discovery that the sterility of certain products did not meet required standards. Specifically, the affected items include the Blood Coagulation Tube 3, with a reported batch identifier of 20160418. The recall highlights a critical quality control issue, ensuring that medical devices comply with established sterility specifications for patient safety. While the document does not detail specific inspection dates, it indicates a self-identified compliance failure by the manufacturer. The National Medical Products Administration (NMPA) serves as the regulatory authority overseeing such medical device recalls in China, providing the platform for public notification and regulatory oversight. As a result, Hebi Zhongxing Medical Supplies Co., Ltd. is recalling the specified batch of containers to prevent potential health risks associated with non-sterile medical products. A Level III recall typically indicates a situation where use of or exposure to a violative product is not likely to cause adverse health consequences. This proactive measure demonstrates the company's commitment to product safety under the regulatory framework administered by the NMPA.