China NMPA Product Recall - Breast biopsy needles and accessories

Bard Medical Technology (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its breast biopsy needles and accessories on May 24, 2019. The company identified a potential leakage risk at the connection point between the breast biopsy needle and the tissue collector, which could compromise device integrity during medical procedures. Operating under the regulatory framework of the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration, Bard Medical Technology (Shanghai) Co., Ltd. reported this critical defect. As a required action, the company is recalling affected product batches, identified by Registration Certificate No.: 20173156309. Additionally, users of these medical devices are strongly advised to meticulously inspect the connection seal after assembly to prevent any potential leakage. This proactive measure aims to ensure patient safety and product efficacy. Further details regarding specific models, specifications, and batch numbers of the impacted products are available in the "Medical Device Recall Event Report Form" provided by the NMPA.