China NMPA Product Recall - Disposable intravenous nutrition infusion bags

The National Medical Products Administration (NMPA) issued a notice on December 20, 2018, detailing a voluntary Class III recall by Baxter Healthcare Corporation. Reported on December 10, 2018, the recall involves disposable intravenous nutrition infusion bags (models H939737 and H938738). The central issue driving the recall is the potential for product leakage during the medication filling process when these bags are utilized. Baxter Healthcare Corporation, the manufacturer, proactively initiated this recall to address the identified product defect. Although the product holds a National Medical Device Registration Certificate (20153662931) in China, the recall primarily impacts international markets. Affected regions encompass Brazil, Chile, Uruguay, Puerto Rico, New Zealand, the United States, Canada, and Hong Kong. Importantly, the NMPA document explicitly states that this recall does not involve the Chinese market, and therefore, no domestic actions are required. This highlights the manufacturer's commitment to global product safety and quality assurance.