China NMPA Product Recall - Groshong NXT PICC Catheter Kit and Accessories

Bard Medical Technology (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its Groshong NXT PICC Catheter Kits and accessories, as announced on July 13, 2021. This action, overseen by the National Medical Products Administration (NMPA) in China, addresses a discovered issue where external connectors on certain batches of these Peripherally Inserted Central Venous Catheter Kits and Accessories may fail to lock securely upon initial connection. The problem was first identified in the U.S. The company has not received reports of serious adverse events related to this specific issue in China. As required actions, Bard Medical Technology (Shanghai) Co., Ltd. will inform customers about procedures for handling these abnormalities and provide necessary replacement parts. The recall pertains to products under Registration Certificate No.: 20173771671, with specific details on affected models and batches provided in the Medical Device Recall Event Report Form.