China NMPA Product Recall - Bone marrow biopsy needle

Kangfusheng (Shanghai) Trading Co., Ltd., the responsible unit in China for manufacturer CareFusion (now part of BD), initiated a voluntary Class II recall of specific 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 defect: compromised sterile packaging. This defect cannot guarantee the product's sterility, posing a risk of local or systemic infections for users. While the issue is visually identifiable before use, and no serious injuries have been reported globally or in China, the potential for harm prompted this action under the NMPA's regulatory oversight for imported medical devices. Required actions include the immediate discarding of all unshipped affected inventory and notifying customers to return previously shipped and sold products to CareFusion's warehouse for proper disposal. This measure ensures patient safety by removing potentially non-sterile devices from circulation.