China NMPA Product Recall - Heat exchange water tank system

Sorin Medical (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its heat exchange water tank system, as reported by the National Medical Products Administration (NMPA) on June 19, 2017. This recall follows an earlier action in 2015, with the company indicating upgraded measures based on previous experiences. The primary concern prompting this action is the significant risk of bacterial infection associated with the affected products. Operating under the oversight of the NMPA, the company is addressing potential safety hazards to protect public health. The specific recall identifier provided is CFDA (Imported) No. 20132454894 (Updated). While no direct inspection dates are detailed in the announcement, the information signifies an ongoing commitment to product safety and regulatory compliance. As part of the required actions, Sorin Medical is systematically withdrawing the identified heat exchange water tank systems from the market. The recall involves specific models, specifications, and batches, with comprehensive details available in the 'Medical Device Recall Event Report Form' attached to the official NMPA notice. This proactive measure by Sorin Medical aims to mitigate the bacterial infection risk and ensure the safety and efficacy of their medical devices.