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

Hospira, Inc. initiated a global, Level 1 voluntary recall of its infusion pumps (Trade Name: Zhenxing) due to critical calibration issues. The recall, reported by the Shanghai Municipal Food and Drug Administration on January 28, 2014, affects pumps manufactured after January 1, 2009, or those with replaced pressure sensors. The primary concern is the misalignment of upper and lower pressure sensors, which can lead to the device failing to detect blockages and thus not issuing crucial alarms, or conversely, generating false alarms. This malfunction poses significant patient safety risks, potentially causing treatment delays, interruptions, or even over-infusion of up to 1 mL. In severe cases, these issues could result in serious injury or death, depending on the patient's condition and treatment. The recall adheres to the regulatory framework outlined in the Ministry of Health of the People's Republic of China Order No. 82, "Administrative Measures for the Recall of Medical Devices (Trial Implementation)." Hospira's required corrective actions include deploying engineers to perform immediate occlusion tests, withdrawing failing pumps for recalibration, incorporating annual occlusion testing into maintenance plans, and revising technical service manuals. The company also committed to notifying all stakeholders via its website and direct communication.