China NMPA Product Recall - Insulin pumps use disposable infusion tubing and needles

The National Medical Products Administration (NMPA) issued notice JGXX-2017-10903 on September 26, 2017, detailing a Class I voluntary recall initiated by Unomedical a/s. The recall, reported by Medtronic (Shanghai) Management Co., Ltd., pertains to disposable infusion tubing and needles used with insulin pumps (Registration Certificate Nos.: 国械注进201636612, 进20173660391, 国械注进20173661681). The core issue involves suspected insulin overinfusion occurring shortly after tubing replacements, a serious defect that poses a risk of hypoglycemia and, in extreme cases, death. The Class I designation highlights the significant health hazards associated with continued use of these products. Operating under the NMPA's regulatory framework, Unomedical a/s is performing this recall to protect patient safety. The mandatory action requires the thorough removal of all impacted disposable infusion tubing and needles from distribution. Comprehensive information, including specific product models, specifications, and batch numbers, is provided in the accompanying 'Medical Device Recall Event Report Form.' This recall is a critical measure to prevent further adverse events stemming from the device's malfunction.