China NMPA Product Recall - Injection pump

Hunan Kangda Biotechnology Co., Ltd. initiated a voluntary Class III recall of its injection pumps (model XB1500202000002 / XB-1500) on August 26, 2020, following a sampling inspection. The core issue identified was that these medical devices did not conform to their registered product technical requirements, indicating a critical non-compliance with established standards. The recall, overseen by the National Medical Products Administration (NMPA) and specifically documented by the Hunan Provincial Drug Administration, targeted 5 units of the affected product. These pumps are designed for constant-rate intravenous infusion in hospital settings, and the recall's impact was concentrated in the domestic market, particularly Zhuzhou, China. In response to this regulatory finding, Hunan Kangda Biotechnology Co., Ltd. took several required actions. Its customer service team proactively contacted all affected customers to coordinate the return of the non-conforming injection pumps. Additionally, as a corrective measure to address the identified deficiencies, the company conducted thorough testing of the audible and visual alarms on the recalled units. This voluntary recall underscores the stringent regulatory expectations under the NMPA framework, emphasizing the importance of medical device manufacturers ensuring their products consistently meet registered technical specifications to safeguard patient health and maintain product reliability.