China NMPA Product Recall - Vacuum blood collection tubes

Chongqing Sanfeng Medical Device Co., Ltd. initiated a voluntary Class II recall for its Vacuum Blood Collection Tubes, specifically the 2.7ml Blood Coagulation Tube, due to a critical manufacturing oversight: the products were not sterilized. This issue affected batch number 1809-01, produced on September 25, 2018. Of the 35,344 units produced, 3,600 were distributed within Chongqing, China. The company reported this recall to the provincial Food and Drug Administration Department on September 30, 2018, operating under the regulatory framework of the National Medical Products Administration (NMPA). The recall was publicly announced on October 30, 2018. As required actions, Chongqing Sanfeng Medical Device Co., Ltd. promptly contacted its distributors and users to retrieve the non-compliant products. The company confirmed that all affected units were successfully recalled and had not been used, thereby preventing potential health risks associated with unsterilized medical devices. This swift action aligns with established medical device recall management protocols to ensure product safety and compliance.