China NMPA Product Recall - Bard® R Mission Disposable Core Biopsy Instrument Kit (Disposable Guided Biopsy Needle)

Bard Peripheral Vascular, Inc., in cooperation with Bard Medical Technology (Shanghai) Co., Ltd., has initiated a voluntary Class III recall of its Bard Mission Disposable Core Biopsy Instrument Kit. This recall, announced by the National Medical Products Administration (NMPA) on June 14, 2023, addresses a significant product defect. The core issue involves specific batches of coaxial cannulas that have an inner diameter and length exceeding the corresponding dimensions of the biopsy needle. This dimensional discrepancy prevents the biopsy needle from being properly inserted into the cannula, thereby hindering its ability to accurately reach the intended target during medical procedures.

Operating under the regulatory oversight of the NMPA, for which the product holds National Medical Device Registration Certificate No. 20212140255, this recall is a necessary action to ensure patient safety and maintain product integrity. While no specific inspection dates are mentioned, the company's proactive measure highlights its commitment to addressing product quality concerns. Further detailed information, including affected product models, specifications, and batch numbers, is provided in the associated Medical Device Recall Event Report Form, guiding healthcare providers on necessary actions.