# China NMPA Product Recall - Insulin pump infusion tubing and needle

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-minimed-and-unodical-as/4923cc82-1976-4e4c-b04b-639f78f86f76/
Source feed: China

> China NMPA product recall for Insulin pump infusion tubing and needle by Medtronic MiniMed and Unodical a/s published September 02, 2013. Recall level: . The National Medical Products Administration (NMPA) issued a document in September 2013, detailing a

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic MiniMed and Unimedical a/s are recalling insulin pump tubing and needles.
- Company Name: Medtronic MiniMed and Unodical a/s
- Publication Date: 2013-09-02
- Product Name: Insulin pump infusion tubing and needle
- Recall Reason: Medtronic's Diabetes Business Unit has identified a potential safety issue when insulin or other fluids come into contact with the interior of the Medtronic Paradigm infusion line connector. After filling the reservoir with bottled insulin (or insulin cartridge), the interior of the infusion line connector is most likely to come into contact with liquid if insulin spills onto the top of the reservoir when removing it from the pipette cap. If this occurs, the insulin may temporarily block the connector's vents, preventing the pump from filling properly. If these vents are blocked, it may result in the infusion of too much or too little insulin, causing hypoglycemia or hyperglycemia.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic MiniMed and Unodical a/s
- Summary: The National Medical Products Administration (NMPA) issued a document in September 2013, detailing a voluntary recall initiated by Medtronic MiniMed and Unomedical a/s, with Medtronic (Shanghai) Management Co., Ltd. as the responsible unit in China. The recall pertains to several models of insulin pump infusion tubing and needles, which were originally imported under CFDA (China Food and Drug Administration) licenses, with over 2 million units imported to China since 1998.
The primary issue identified is a potential safety concern arising when insulin or other liquids come into contact with the internal components of the infusion line connector. This can occur, for instance, if insulin spills onto the reservoir during removal from the pipette cap. Such liquid contact has been found to temporarily block the connector's vent, impeding proper pump filling. This malfunction can lead to either over-infusion or under-infusion of insulin, posing a serious health risk of hypoglycemia or hyperglycemia for users.
In response to this significant safety finding, Medtronic MiniMed and Unomedical a/s are voluntarily recalling the affected products globally. The required actions include informing both individual users and healthcare professionals in hospitals about the incident, explaining the mechanism of temporary vent blockage, and providing clear corrective action instructions to prevent liquid contact and subsequent blockage. These instructions are to be incorporated as an addendum to the product manuals. Additionally, provincial, autonomous region, and municipal food and drug administrations were tasked by the NMPA to intensify their supervision of these recalled medical devices.

Company: https://www.globalkeysolutions.net/companies/medtronic-minimed-and-unodical-as/83fc11a3-dce9-4062-bd4d-fb154cd097f4/