China NMPA Product Recall - Bone marrow biopsy needle

Kangfusheng (Shanghai) Trading Co., Ltd., representing manufacturer CareFusion (now part of BD), initiated a voluntary Class II recall of specific Bone Marrow Biopsy Needles, detailed in a National Medical Products Administration (NMPA) document dated April 6, 2017. The recall, internally reported by CareFusion on February 23, 2017, addresses a critical defect in the sterile packaging of the affected devices. The core issue is that compromised packaging cannot guarantee product sterility, potentially leading to local or systemic infections in users. Although the problem is identifiable by visual inspection before use, and no serious injuries have been reported globally or within China, the company is taking decisive action under NMPA medical device regulations. Required actions include the immediate disposal of all affected unshipped inventory. Additionally, customers who have received or purchased these products are to be notified via letter to return the specified batch numbers to the CareFusion warehouse for proper disposal, ensuring patient safety.