China NMPA Product Recall - X-Force N30 Nephrostomy Balloon Dilation Catheter

Bard Medical Technology (Shanghai) Co., Ltd., a subsidiary of manufacturer C.R. Bard, Inc., initiated a voluntary Class III product recall for its X-Force N30 Nephrostomy Balloon Dilation Catheter. This action was reported to the National Medical Products Administration (NMPA), formerly CFDA, on October 25, 2016, with public notification on December 7, 2016. The primary issue involved a packaging error for product code 996081, where a 30Fr sheath was incorrectly included in packages that should have contained a 24Fr sheath. This error affects 177 units globally, with 170 units distributed within the Chinese market. The X-Force Nephrostomy Balloon Dilation Catheter is designed for dilating the nephrostomy tract and facilitating working sheath placement. Required actions for this recall include immediately stopping the distribution and use of all affected products, quarantining them, and notifying relevant distributors and hospitals to ensure the prompt return of all identified faulty items to the company.