China NMPA Product Recall - Pressure pump unit

Medtronic, Inc. initiated a voluntary recall on February 13, 2014, for a specific batch of its Pressure Pump Devices (model AC2205P, batch number 50755851). This action was reported to China's National Medical Products Administration (NMPA) on February 14, 2014. The primary issue identified was an incorrect main label title on the outer carton; products were mistakenly identified as 'Everest 30 Survival Kit' when they should have been labeled 'Everest 20 Survival Kit.' All other product labels and contents were correct, and Medtronic confirmed that this labeling discrepancy had not resulted in any adverse health consequences or patient harm. Although the affected products were not distributed or sold in China, Medtronic (Shanghai) Management Co., Ltd. served as the local reporting unit. Under its regulatory framework, the NMPA responded by requesting provincial and regional Food and Drug Administrations to strengthen their oversight of similar medical devices, emphasizing the importance of accurate product identification for global market safety.