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, as reported by the National Medical Products Administration (NMPA) on February 21, 2020, and further detailed on March 9, 2020, by the Shanghai Municipal Drug Administration. This action stems from the discovery of a potential leakage risk at the connection point between the breast biopsy needle and the tissue collector. The company advises users to meticulously check the connection seal after assembly to prevent leakage. This recall serves as an update to a prior recall of the same product, initially reported on May 24, 2019. Bard Medical Technology (Shanghai) Co., Ltd. identified an additional 10 batches, including 8 imported into China, that were not encompassed in the earlier notice but presented the identical potential issue. The affected products are identifiable by Registration Certificate No. 20173156309, with specific models, specifications, and batches detailed in the accompanying "Medical Device Recall Event Report Form." This proactive measure, undertaken by the company under the oversight of China's medical product regulatory bodies, aims to address the identified product safety concern and safeguard patient well-being.