# China NMPA Product Recall - subcutaneous electrodes

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-xomed-inc/71a5eea7-b1b0-4cb2-bf12-3925598066bb/
Source feed: China

> China NMPA product recall for subcutaneous electrodes by Medtronic Xomed, Inc. published August 24, 2015. Recall level: Class III Recall. On August 24, 2015, Medtronic (Shanghai) Management Co., Ltd., operating as the responsible unit in 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic (Shanghai) Management Co., Ltd. voluntarily recalls subcutaneous electrodes
- Company Name: Medtronic Xomed, Inc.
- Publication Date: 2015-08-24
- Product Name: subcutaneous electrodes
- Recall Level: Class III Recall
- Recall Reason: The subcutaneous electrodes were incorrectly labeled, mistakenly stating "validity period of 8 years" instead of the "4-year validity period" required for registration in China.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic Xomed, Inc.
- Summary: On August 24, 2015, Medtronic (Shanghai) Management Co., Ltd., operating as the responsible unit in China for manufacturer Medtronic Xomed, Inc., announced a voluntary Class III recall concerning subcutaneous electrodes. This regulatory action, overseen by the National Medical Products Administration (NMPA), stemmed from an identified mislabeling issue. The affected medical devices were erroneously marked with an "8-year validity period," conflicting with the "4-year validity period" legally mandated under Chinese registration requirements. The recall involved 438 units of subcutaneous electrodes, product models 8227411, 8227412, 8227465, and 8227103, which are designed for subcutaneous placement and use with neuromonitoring systems to record electrical signals. Medtronic’s internal assessment determined that, despite the labeling error, the misstatement did not pose a health hazard, as scientific evidence supported the product's packaging and sterility maintaining an 8-year shelf life. Therefore, no adverse health consequences were anticipated from continued use. However, to address the regulatory non-compliance, Medtronic outlined specific corrective actions. These included issuing notification letters to all affected customers and facilitating the replacement of the mislabeled products. Furthermore, the company was mandated to retrieve and subsequently destroy all recalled units to align with the NMPA's stringent medical device standards. This comprehensive approach aimed to rectify the labeling discrepancy and uphold product integrity within the Chinese market.

Company: https://www.globalkeysolutions.net/companies/medtronic-xomed-inc/6ab04f9c-4587-45b0-ab74-0dfb3aa38e32/