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

The National Medical Products Administration (NMPA) issued a recall notice on February 13, 2017, regarding the Disposable Human Arterial Blood Sample Collector. The manufacturer, Radiometer Medical ADS, and its Chinese unit, Radiometer Medical Equipment (Shanghai) Co., Ltd., initiated this recall, which was reported on October 12, 2016. The primary concern stemmed from reports indicating that some needles in a specific batch (model UK57 956-522) exhibited rusting. This quality issue for the product, registered under National Food and Drug Administration (FDA) No. 2013 3564963, could compromise its intended use for arterial blood sample collection and analysis. In response, the company was required to notify all affected customers, instructing them to verify their current stock of the product. Any remaining units of the identified batch (595 boxes in China) were to be returned. This action falls under the NMPA's regulatory oversight to ensure the safety and efficacy of medical devices distributed within China.