China NMPA Product Recall - Vacuum blood collection tubes

Chongqing Sanfeng Medical Device Co., Ltd. initiated a Level II voluntary recall of its vacuum blood collection tubes due to a critical sterilization failure. The affected product, specifically the Blood Coagulation Tube 2.7ml from batch number 1809-01, was produced on September 25, 2018, with 3,600 units being subject to the recall. These tubes are designed for the collection and processing of clinical human venous blood specimens, making proper sterilization paramount for patient safety.The recall was formally reported by Chongqing Sanfeng Medical Device Co., Ltd. on September 30, 2018, and subsequently published by the National Medical Products Administration (NMPA) on April 12, 2021, with oversight from the Chongqing Municipal Drug Administration. The core issue identified was that the products were not sterilized, a significant non-compliance that prompted immediate action.The company's required actions included contacting distributors and users to facilitate the retrieval of all non-compliant products. Chongqing Sanfeng Medical Device Co., Ltd. confirmed that all affected units were recalled in accordance with its established recall management system, and crucially, reported that the recalled products had not been used. This swift response aligns with regulatory expectations to mitigate potential health risks associated with unsterilized medical devices.