China NMPA Product Recall - Disposable human arterial blood sample collection device

Radiometer Medical ApS, through its Chinese entity Radiometer Medical Device (Shanghai) Co., Ltd., initiated a product recall for its Disposable Human Arterial Blood Sample Collectors. This action, reported on October 12, 2016, and published by the National Medical Products Administration (NMPA) on December 7, 2016, was prompted by reports of rust appearing on some needles within affected product batches. The recall specifically impacts product model/specification UK57 956-522, with 595 boxes imported and sold in China. The regulatory framework governing this medical device is overseen by China's NMPA, as indicated by the import registration certificate number (No. 2013 3664963). In response to this quality concern, Radiometer Medical Device (Shanghai) Co., Ltd. implemented corrective actions. These actions involved notifying all customers about the issue and instructing them to inspect their stock for any remaining affected products. Customers possessing these products were requested to return all units immediately. This proactive measure aims to ensure patient safety and product quality compliance under NMPA regulations.