China NMPA Product Recall - Infusion pump (product name: Zhenxing)

Hospira, Inc. initiated a voluntary global recall of its Zhenxing infusion pumps, as reported by Hospira (Shanghai) Trading Co., Ltd. on July 17, 2013. This recall addresses critical malfunctions posing risks of treatment delays, interruptions, and potentially serious injury or death. The main issues include battery leakage (Class I), where alkaline batteries can damage internal components causing unexpected device shutdown; low lithium battery voltage (Class I), rendering the device inoperable and clearing settings; and drive motor reversal (Class II), which can lead to additional medication delivery or device malfunction at low flow rates. This action aligns with China's Ministry of Health Order No. 82, "Administrative Measures for the Recall of Medical Devices (Trial Implementation)." Required actions involve customer checks for battery leakage, replacing lithium batteries older than three years, and backing up historical data. Furthermore, users are advised against using the device on infants under two years old or at flow rates below 2.0 mL/hr, with appropriate warnings to be added to product instructions. Hospira is communicating directly with distributors and end customers and will report recall progress to the National Medical Products Administration.