# China NMPA Product Recall - Insulin pump disposable infusion tubing and needles Infusion Set

Source: https://www.globalkeysolutions.net/records/china_product_recall/unomedical-as/6432733c-9646-4269-b25a-8ed73dfe5a5b/
Source feed: China

> China NMPA product recall for Insulin pump disposable infusion tubing and needles Infusion Set by Unomedical a/s published November 14, 2022. Recall level: Level 2 Recall. The National Medical Products Administration (NMPA) has announced a Class II voluntary recall initia

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Uninomedical a/s is voluntarily recalling disposable infusion tubing and needles for insulin pumps.
- Company Name: Unomedical a/s
- Publication Date: 2022-11-14
- Product Name: Insulin pump disposable infusion tubing and needles Infusion Set
- Recall Level: Level 2 Recall
- Recall Reason: Labeling error
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Unomedical a/s
- Summary: The National Medical Products Administration (NMPA) has announced a Class II voluntary recall initiated by Uninomedical a/s for its Disposable Infusion Set for Insulin Pumps. This recall was published on November 14, 2022, and was reported by Medtronic (Shanghai) Management Co., Ltd. on behalf of the manufacturer. The core issue driving this action is a labeling error identified on specific models and batches of the infusion sets, which hold Registration Certificate Nos.: 20163141282 and 20173141681. While specific inspection dates are not provided, the company proactively reported the discrepancy. A Class II recall indicates a situation where product use could lead to temporary or medically reversible health consequences, or where serious adverse consequences are unlikely. The required action involves the voluntary removal of these affected products from distribution to correct the labeling inaccuracy and ensure compliance. Detailed information on the specific models, specifications, and batch numbers impacted is available in the associated "Recall Event Report Form."

Company: https://www.globalkeysolutions.net/companies/unomedical-as/198554ef-2c44-49be-9ed9-bf15c171ef7c/