China NMPA Product Recall - Disposable needlestick-proof indwelling intravenous catheter BD Nexiva™ Closed IV Catheter System

The National Medical Products Administration (NMPA) announced on November 14, 2022, a voluntary Class III recall initiated by Becton Dickinson Infusion Therapy Systems, Inc., specifically involving its Becton Medical Devices (Shanghai) Co., Ltd. subsidiary. The recall targets certain models and batches of the Single-Use Needle-Punch Protection Indwelling Vein Catheter System BD Nexiva™ Closed IV Catheter System. The core issue prompting this action is the potential for the needle tip protection device to prematurely detach from the transparent catheter adapter during clinical use. This detachment could expose the needle shaft, posing a risk of needlestick injury to healthcare professionals and potentially impacting patient safety. The NMPA oversees this recall under its regulatory framework for medical devices in China, ensuring that the company takes appropriate measures to address the identified product defect. Becton Dickinson is required to remove the affected products from circulation and has provided detailed information on the specific models and batches through a "Medical Device Recall Event Report Form" to facilitate the recall process and ensure compliance.