China NMPA Product Recall - Hollow fiber dialysis machine

On August 13, 2015, the National Medical Products Administration (NMPA) publicized a voluntary Class II recall initiated by Gambro Kidney Care Products (Shanghai) Co., Ltd. for the Hollow Fiber Dialyzer, model Polyflex 14L, manufactured by Gambro Dialysatoren GmbH. This recall, affecting 15,120 units imported and sold in Mainland China, addresses a critical quality issue: the presence of air bubbles in the polyurethane encapsulation material. This defect can cause leakage between the blood and dialysate sides, potentially compromising the safety and efficacy of hemodialysis treatment for patients with renal failure. The product was registered under CFDA (Imported) No. 2012 3454528. As part of the recall actions, Gambro Kidney Care Products (Shanghai) Co., Ltd. committed to issuing recall notices to all affected customers and retrieving all remaining unused problematic products from the market for destruction. This measure was undertaken to mitigate risks and ensure compliance with medical device quality standards.