China NMPA Product Recall - Vacuum blood collection tubes

Chongqing Sanfeng Medical Device Co., Ltd. initiated a voluntary Level II recall for specific batches of its vacuum blood collection tubes due to a critical sterilization failure. The recall, reported by the company on September 30, 2018, and publicized by the National Medical Products Administration (NMPA) on October 22, 2020, primarily affected the Blood Coagulation Tube 2.7ml (Batch Number: 1809-01, Production Date: September 25, 2018), with 3,600 units identified for recall out of a production quantity of 35,344 units. The core issue was that these medical devices were unsterilized, posing a significant safety risk for their intended use in collecting, transporting, preserving, and processing human venous blood specimens. Operating under the regulatory oversight of the NMPA and Chongqing Municipal Drug Administration, the company's required actions involved immediately contacting distributors and users to retrieve the affected products. Chongqing Sanfeng Medical Device Co., Ltd. confirmed that all identified unsterilized products were successfully recalled and had not been used by patients or facilities, demonstrating adherence to their internal recall management protocols. This swift action aimed to mitigate potential health hazards associated with non-sterile blood collection equipment.