China NMPA Product Recall - Portable automated peritoneal dialysis machine

On October 15, 2012, the National Medical Products Administration (NMPA) published information regarding a voluntary recall initiated by Baxter Healthcare Corporation. The recall, first reported by Baxter on September 17, 2012, pertains to certain batches of its Portable Automated Peritoneal Dialysis Machines (Model/Specification: 5C4474). The primary issue identified was that some products were manufactured using 230V HomeChoice power cords that did not meet internal product quality standards and regulatory requirements, specifically lacking approval from Baxter's Device Research and Development Organization. This non-compliance presents significant potential risks, including treatment delays of up to 24 hours for patients. More critically, there is a risk of electric shock or fire, which could lead to severe outcomes such as burns, scarring, or even death. Under the oversight of the NMPA, though the recall explicitly does not involve the Chinese market, the administration requested provincial food and drug administrations to enhance their management concerning this issue. The required corrective action for affected products in 27 countries worldwide involves replacement of the problematic components by a qualified maintenance engineer.