China NMPA Product Recall - Arterial blood collection device

BD Medical Devices (Shanghai) Co., Ltd., a subsidiary of Becton, Dickinson and Company, issued a voluntary recall for its Arterial Blood Collection Devices (Model/Specification: 364389, Batch Number: 5324741) in December 2016. This recall, reported to the National Medical Products Administration (NMPA), was prompted by an internal discovery that a limited number of product packages exhibited partial seal cracks. These integrity breaches, varying in size from nearly imperceptible to 8.3 mm, rendered the products non-sterile. This issue presented a significant health hazard, as compromised sterility could lead to contamination by pathogenic bacteria, thereby risking patient safety during arterial blood sample collection for in vitro diagnostic testing. The recall affected approximately 22,400 units produced, with 19,500 units distributed within China. In adherence to regulatory requirements, the company's corrective actions involved immediately notifying customers through written letters about the incident and facilitating the recall and replacement of all affected devices to ensure product safety and compliance.