China NMPA Product Recall - Peritoneal dialysis machine

The National Medical Products Administration (NMPA) issued a recall notice on September 6, 2015, regarding Peritoneal Dialysis Machines (Model 5C4474, Registration No. CFDA (Imported) No. 20122453672) manufactured by Baxter Healthcare SA. Baxter Medical Supplies Trading (Shanghai) Co., Ltd., as the responsible unit in China, reported the voluntary recall. The primary violations stemmed from two regional issues: in Chile, the technical service center potentially used parts from other equipment during repairs, leading to concerns about excessive test results and inadequate post-repair documentation; in India, insufficient electrical safety testing was identified for machines returned for quality verification. For the Chilean recall, affected machines were to be returned for re-inspection and part replacement. In India, a plan for re-inspection of machines at the service center was initiated, despite no reported complaints. Baxter Healthcare SA explicitly stated that the recalled products were not distributed or sold in mainland China. Consequently, under the NMPA's regulatory framework, no direct action was required within the Chinese market. Provincial and municipal food and drug administrations were, however, requested to enhance their general supervision and management of such medical devices.