# China NMPA Product Recall - Integrated membrane oxygenator

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-inc/b935fc58-430e-4af4-b343-804cf953d30c/
Source feed: China

> China NMPA product recall for Integrated membrane oxygenator by Medtronic Inc. published December 05, 2016. Recall level: . Medtronic Inc. initiated a voluntary global recall of its integrated membrane oxygenators, as detail

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic Inc. recalls integrated membrane oxygenators.
- Company Name: Medtronic Inc.
- Publication Date: 2016-12-05
- Product Name: Integrated membrane oxygenator
- Recall Reason: Burrs were found in the plastic material at the arterial sampling port of the oxygenator.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic Inc.
- Summary: Medtronic Inc. initiated a voluntary global recall of its integrated membrane oxygenators, as detailed in a National Medical Products Administration (NMPA) report published on December 5, 2016. The recall, reported by Medtronic (Shanghai) Management Co., Ltd. on November 15, 2016, addressed a quality concern involving contaminants, specifically burrs, identified within the plastic material of the oxygenator's arterial sampling port. Although the full potential impact of these burrs had not been conclusively determined, Medtronic proceeded with the recall as a precautionary measure to uphold patient safety standards. These oxygenators are critical for extracorporeal circulation during cardiopulmonary bypass surgery, facilitating blood oxygenation. The recall primarily impacted markets in the USA, Canada, Germany, Greece, and the UK. Notably, Medtronic confirmed that no affected products were sold or imported into the Chinese market. Therefore, no direct corrective actions, such as product returns or modifications, were required from Chinese medical facilities. Under its regulatory framework, the NMPA directed provincial and municipal food and drug administrations to strengthen their supervision over this type of medical product. This emphasizes a commitment to maintaining high standards of medical device safety and quality across the supply chain.

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