China NMPA Product Recall - Extension tubes and fittings

On April 30, 2019, Baxter Medical Products Trading (Shanghai) Co., Ltd. initiated a voluntary Class II recall for specific batches of its extension tubes and fittings. This action, reported under the oversight of the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration, stemmed from a potential issue involving a crack between the Luer connector and the cap of these medical devices. The company decided to recall these products from the global market. Specifically, the recall targeted extension tubes and fittings (Registration Certificate No.: 国械注进20173660386) that had been imported into China but had not yet been commercially sold. Baxter's proactive measure was implemented to prevent potential safety risks associated with the identified defect, ensuring that only compliant and safe medical devices are available. Detailed information about the affected models and specifications was provided in the associated "Medical Device Recall Event Report Form."