China NMPA Product Recall - Body temperature controller

Bard Medical Technology (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its temperature controllers, specifically the Arctic Sun model, as announced by the National Medical Products Administration (NMPA) on August 29, 2017. The recall was prompted by a critical safety concern: if the affected devices are used for more than 2000 hours without preventative maintenance, it could lead to the failure of certain internal components. This proactive measure by Bard Medical Technology highlights the importance of regular product upkeep to ensure continued functionality and patient safety. The recall action applies to temperature controllers with Registration No. CFDA (Imported) No. 2012213086. The company provided detailed information regarding the specific models, specifications, and batch numbers of the affected products in a "Medical Device Notice" and "Medical Device Recall Event Report Form," which were attached to the NMPA's publication. The NMPA, as the regulatory body, facilitated the public notification of this recall, underscoring its role in overseeing medical device safety within China. Affected healthcare providers and users were advised to consult the provided documentation for comprehensive details on the recall and necessary actions.