China NMPA Product Recall - Breast localization needle

Bard Medical Technology (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its breast positioning needles, as announced by the National Medical Products Administration (NMPA) on June 19, 2017. The primary reason for this action is the potential presence of non-electromagnetically compatible components within the medical devices. This compatibility issue could potentially affect the safety or performance of the needles during medical procedures. The recalled products, identified under Registration No.: CFDA 2014 No. 3151392, involve specific models, specifications, and batch numbers. Detailed information regarding these affected products is available in the "Medical Device Recall Event Report Form," which was provided as an attachment to the NMPA's announcement. This voluntary recall by Bard Medical Technology (Shanghai) Co., Ltd. demonstrates the company's commitment to patient safety and adherence to regulatory standards overseen by the NMPA. The Class II designation indicates that the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. The company is taking proactive steps to remove these potentially problematic devices from circulation to mitigate any associated risks to healthcare professionals and patients.