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

The National Medical Products Administration (NMPA) has announced a voluntary Class III recall initiated by Becton Dickinson Infusion Therapy Systems, Inc., concerning their single-use needle-punch-proof indwelling vein catheter system, the BD Nexiva™ Closed IV Catheter System. This action, reported by Becton Medical Devices (Shanghai) Co., Ltd., on October 27, 2021, stems from a critical manufacturing issue: inadequate packaging sealing identified in specific models and batches of the product. The primary concern is that compromised packaging could affect the sterility or integrity of the medical device, potentially posing risks to patient safety during clinical use. As a Class III recall, this indicates a situation where the use of or exposure to a violative product is not likely to cause adverse health consequences. Becton Dickinson Infusion Therapy Systems, Inc. is taking proactive steps to retrieve the affected products from the market to ensure compliance with quality and safety standards. Further details regarding the specific product models and batch numbers involved are available in the accompanying "Medical Device Recall Event Report Form" attachments. This recall underscores the continuous commitment of regulatory bodies and manufacturers to uphold product quality and patient safety within the medical device industry.