China NMPA Product Recall - Cardiopulmonary exchange water tank

Sorin Medical (Shanghai) Co., Ltd. initiated a voluntary Level III recall of its Fenjiu cardiopulmonary resuscitation devices, specifically Cardiopulmonary Exchange Water Tanks. This action, reported to the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration (as per Medical Device Recall 2018-276), was announced on December 11, 2018. The recall stems from a critical issue identified in a subset of the affected products after clinical use. Investigations revealed a rapid and premature drop in hydrogen peroxide concentration to zero within one day. Further analysis linked this issue to the degradation of the nickel coating on the device's coils, leading to the exposure of copper. The rapid loss of hydrogen peroxide was subsequently attributed to a chemical reaction occurring between the exposed copper and the hydrogen peroxide solution. This defect potentially compromises the device's intended function and patient safety. Sorin Medical (Shanghai) Co., Ltd. has issued a formal recall notice, detailing product models, specifications, and batch numbers in an attached Medical Device Recall Event Report Form, to facilitate the removal of these devices from circulation and mitigate potential risks.