China NMPA Product Recall - Disposable intravenous nutrition infusion bags

Baxter Healthcare Corporation, through its agent Baxter Medical Supplies Trading (Shanghai) Co., Ltd., initiated a voluntary Class III recall of its disposable intravenous nutrition infusion bags. This action was reported to the National Medical Products Administration (NMPA) on December 10, 2018, and publicly announced on December 25, 2018. The main issue prompting the recall was the potential for product leakage when the infusion bags are used to fill medications, affecting product models H939737 and H938738. This voluntary recall operates under the NMPA's regulatory framework, referencing National Medical Device Registration Certificate No. 20153662931. While the recall impacted international markets such as Brazil, Chile, Uruguay, Puerto Rico, New Zealand, the United States, Canada, and Hong Kong, it explicitly did not involve the Chinese market. Consequently, no domestic actions or corrective measures were required within China.