China NMPA Product Recall - Alaris GW Volumetric Pump

CareFusion Switzerland 317 Sarl initiated a voluntary Class III recall of its Alaris GW Volumetric Pump, as reported by Kangfusheng (Shanghai) Trading Co., Ltd. to the National Medical Products Administration (NMPA) on January 6, 2021. The recall stems from overseas complaints indicating potential abnormal operational issues when incompatible or mismatched infusion sets are used with specific models and batches of the device. This corrective action is implemented under the regulatory oversight of the NMPA, referencing the product's existing Registration Certificate (CFDA (Imported) 2010 No. 3541888 (Revised)). While no specific inspection dates are cited, the recall is a direct response to reported product performance concerns. As a required action, CareFusion Switzerland 317 Sarl is undertaking a voluntary recall. Affected parties are directed to consult the 'Medical Device Recall Event Report Form' for comprehensive details regarding the specific models, specifications, and batch numbers involved in this recall. This measure aims to address the identified safety concern and ensure the continued safe use of medical devices.