China NMPA Product Recall - Aquarius Continuous Blood Purification Equipment

Edward Lifesciences LLC, in conjunction with its Chinese responsible unit, Baxter Medical Supplies Trading (Shanghai) Co., Ltd., initiated a voluntary global recall of specific Aquarius Continuous Blood Purification Equipment models (GE-F082-00/GE-F095-00/GE-F096-00/GE-F097-00). This recall, announced by the National Medical Products Administration (NMPA) on January 19, 2012, addresses a critical safety concern. The primary issue identified is wheel damage occurring during the machine's movement, particularly on uneven surfaces or when wheels are locked. This defect can lead to the equipment losing balance, tipping over, and potentially causing personal injury to users or patients. The recall affects 539 units imported into China, with serial numbers ranging from 101 to 3534. Under the regulatory oversight of the NMPA (formerly CFDA), Edward Lifesciences LLC is implementing corrective actions. These include deploying local service engineers to inspect all affected Aquarius machines. During the next scheduled routine maintenance, engineers will ensure proper wheel installation, verify that wheel torque is within defined specifications, and confirm that helical grooves effectively prevent unexpected sprocket axle release, following detailed technical bulletins. Provincial Food and Drug Administrations were also requested to enhance supervision of such products.