China NMPA Product Recall - Breast Biopsy Probe and Accessories

Bard Peripheral Vascular, Inc., with reporting from Bard Medical Technology (Shanghai) Co., Ltd., has initiated a voluntary Class III recall for specific models and batches of its breast biopsy probes and related accessories. This action, publicly reported on December 16, 2022, was prompted by the critical discovery of foreign objects located at the tip of certain breast biopsy needles. This quality issue poses a potential risk to patient safety during medical procedures. The National Medical Products Administration (NMPA) is the regulatory authority overseeing this recall, ensuring compliance with medical device safety standards. The required action involves the comprehensive removal of the affected breast biopsy probes, specifically those identified under Registration Certificate No.: 20173016309, from the market. Further detailed information concerning the exact product models, technical specifications, and impacted batch numbers is available in the official "Medical Device Recall Event Report." This measure highlights the NMPA's stringent oversight in maintaining the safety and efficacy of medical devices within its jurisdiction.