China NMPA Product Recall - Bone marrow biopsy needle

Kangfusheng (Shanghai) Trading Co., Ltd., as the responsible unit in China for manufacturer CareFusion (now part of BD), initiated a voluntary recall of Class II bone marrow biopsy needles. The recall, reported on February 23, 2017, and published by the National Medical Products Administration (NMPA) on March 17, 2017, addresses a critical issue with the product’s sterile packaging. The core problem is a defect in the aseptic packaging, which compromises the product's sterility and carries a potential risk of local or systemic infection for users. While the packaging integrity issue is visually identifiable before use, and no serious injuries or illnesses have been reported globally or within China, the company is taking proactive measures. Under the NMPA regulatory framework for medical devices, the company is implementing specific corrective actions. These include the immediate discarding of any unshipped CareFusion inventory. For products already distributed and sold, customers are being notified through official letters to return all affected batch numbers to the CareFusion warehouse for proper disposal. This ensures the removal of potentially compromised devices from circulation and mitigates patient safety risks.