China NMPA Product Recall - Continuous blood purification equipment

Guangzhou Delang Medical Equipment Co., Ltd. has initiated a voluntary Level 3 recall for its Continuous Blood Purification Equipment, as announced by the National Medical Products Administration (NMPA) on October 24, 2018. The recall stems from issues identified during random inspections, reported on September 27, 2008.

The main violations include the equipment's low-limit alarm setting value, which failed to meet the specified 1.3 kPa (10 mmHg) minimum required by YY 0645-2008 and YZB/SWI 3166-2015 for continuous blood purification. Additionally, the external marking for electric shock protection symbols (B, BF, CF) was non-compliant with GB9706.1-2007, a key safety standard for medical electrical equipment.

Only one unit from the affected batch was inspected and found non-compliant, with three additional units in company stock exhibiting similar labeling issues. None of these products were sold, and no related adverse event reports have been received. Guangzhou Delang has sealed all four non-compliant devices. The manufacturer, Infomed S.A., is sending engineers to replace the faulty labels. Post-replacement, the equipment will undergo re-testing at the Guangzhou Medical Device Quality Supervision and Inspection Center to ensure full compliance with regulatory standards.