China NMPA Product Recall - Cardiopulmonary exchange water tank

Sorin Medical (Shanghai) Co., Ltd. initiated a voluntary Level III recall for its cardiopulmonary exchange water tanks, vital components within cardiopulmonary resuscitation devices. This action, publicly reported by the National Medical Products Administration (NMPA) on December 5, 2018, and referenced by the Shanghai Food and Drug Administration, addresses a critical product deficiency. The company discovered that a small number of the affected devices, after a period of clinical use, exhibited a rapid and complete loss of hydrogen peroxide concentration within one day. Investigations determined that this rapid depletion was due to the degradation of the nickel coating on the internal coils, which led to the exposure of underlying copper. The exposed copper then reacted with the hydrogen peroxide, causing its swift breakdown. As a result, Sorin Medical (Shanghai) Co., Ltd. is undertaking a comprehensive recall, impacting devices with specific registration certificate numbers (CFDA Import/Export No. 20043540298, CFDA Import/Export No. 20082450403, CFDA Import/Export No. 20132454894, CFDA Import/Export No. 20172452137). The required action involves a full recall of the identified product models, specifications, and batch numbers, with detailed information available in the "Medical Device Recall Event Report Form," to safeguard patient safety and maintain device efficacy.