# China NMPA Product Recall - Drug infusion system

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-inc/55655e1a-53aa-4f87-a952-3da040e8e2c4/
Source feed: China

> China NMPA product recall for Drug infusion system by Medtronic Inc. published May 04, 2015. Recall level: . The National Medical Products Administration (NMPA) announced on May 4, 2015, a voluntary recall ini

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic Inc. recalls its drug infusion systems in the United States.
- Company Name: Medtronic Inc.
- Publication Date: 2015-05-04
- Product Name: Drug infusion system
- Recall Reason: The alarm sound may malfunction.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic Inc.
- Summary: The National Medical Products Administration (NMPA) announced on May 4, 2015, a voluntary recall initiated by Medtronic Inc. concerning its drug infusion systems. The recall, indexed as JGXX-2015-10091, was prompted by a potential issue involving alarm malfunction within these medical devices. The affected product, distributed by Medtronic (Shanghai) Management Co., Ltd., holds Registration Certificate No. CFDA (Imported) 2010 No. 3543342 (Revised). Despite the recall, Medtronic stated that the specific batch of recalled products was not sold within China. The regulatory framework for this action falls under the NMPA's authority, which subsequently requested all provincial, autonomous region, and municipal food and drug administrations to enhance their supervision and management of similar products to ensure public safety and compliance with medical device regulations. This measure highlights the continuous monitoring and proactive steps taken by regulatory bodies in China in response to potential product safety concerns, even when products are not distributed domestically.

Company: https://www.globalkeysolutions.net/companies/medtronic-inc/398d5f72-c7d2-4c97-94fc-fbef4cf2336d/