China NMPA Product Recall - Hemodialysis machine

On September 1, 2015, Gambro Lundia AB, Monitor Division, initiated a voluntary recall of its AK 95 S hemodialysis machines. This recall was reported to the National Medical Products Administration (NMPA) by Gambro Kidney Care Products (Shanghai) Co., Ltd., the product's distributor in China. The primary issue stemmed from the potential use of salvaged parts from other medical devices during repairs of 15 AK95S machines by a technical service center in Chile. The affected products are identified under Registration Certificate No. CFDA (Imported) No. 20083450513. It is crucial to note that the recalled products were not sold, nor does the recall involve, the mainland China market. As required actions, the company is tasked with inspecting the 15 implicated AK95S hemodialysis machines and replacing any necessary parts. Furthermore, the NMPA has instructed its provincial, autonomous region, and municipal food and drug administrations to strengthen their oversight and management of similar medical devices to uphold product integrity and patient safety.