China NMPA Product Recall - Ureteral dilation balloon catheter (ASCEND AQ), Nephrostomy balloon catheter (Ultraxx)

Cook Incorporated voluntarily recalled its Ureteral Dilatation Balloon Catheter (ASCEND AQ) and Nephrostomy Balloon Catheter (Ultraxx) due to critical packaging labeling errors. The recall report, initially dated February 16, 2016, and further documented on January 28, 2018, was overseen by China's National Medical Products Administration (NMPA), formerly CFDA.

The core issue stemmed from customer complaints indicating that product packaging for the nephrostomy balloon catheter and kit incorrectly contained a ureteral dilation balloon catheter. This significant mislabeling posed a potential risk of patient harm if an incorrect device was utilized during medical procedures. The company, through its Chinese entity Cook (China) Medical Trading Co., Ltd., confirmed the recall was initiated to prevent such adverse events.

While the specific recalled batches were not sold within the Chinese market, alleviating the need for direct corrective actions on these products in China, the NMPA's regulatory framework prompted a broader response. Provincial and municipal Food and Drug Administrations were directed to enhance their supervision and management over similar medical devices, ensuring continued public safety and compliance with regulatory standards.