China NMPA Product Recall - Peripherally inserted central venous catheter (PowerPICC) Catheter, Peripherally inserted central venous catheter (PowerPICC SOLO Catheter)

The National Medical Products Administration (NMPA) announced a Class I voluntary recall initiated by manufacturer Bard Access Systems, Inc., and reported by Bard Medical Technology (Shanghai) Co., Ltd. Published on 2025-06-04, this recall, under NMPA Index No. JGXX-2025-10069, addresses an increase in complaints related to material fatigue leakage. The issue stems from resin raw materials used in specific product batches. The affected devices include the PowerPICC Catheter (National Medical Device Registration Certificate 20173031259) and the PowerPICC SOLO Catheter (National Medical Device Registration Certificate 20153032632). While specific inspection dates are not detailed in this announcement, the Class I designation indicates that the product defect could lead to serious adverse health consequences or death. Bard Access Systems, Inc. is actively recalling these products from the market, with comprehensive details regarding models, specifications, and batch numbers provided in the accompanying "Medical Device Recall Event Report Form." This action underscores the critical need for stringent material quality control to safeguard patient health and maintain product integrity in medical devices.