# China NMPA Product Recall - Monopolar surgical electrode

Source: https://www.globalkeysolutions.net/records/china_product_recall/megadyne-medical-products-inc/dfe2efaf-892c-462a-a6d3-32930837e7e3/
Source feed: China

> China NMPA product recall for Monopolar surgical electrode by Megadyne Medical Products Inc. published July 14, 2023. Recall level: Level 3 Recall. The National Medical Products Administration (NMPA) announced a voluntary Class III recall of monopo

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Megadyne Medical Products Inc. is voluntarily recalling its monopolar surgical electrodes.
- Company Name: Megadyne Medical Products Inc.
- Publication Date: 2023-07-14
- Product Name: Monopolar surgical electrode
- Recall Level: Level 3 Recall
- Recall Reason: Liquid infiltration may cause intermittent activation, failure to activate, or automatic activation of the product.
- Discovering Company: Shanghai Maisheng Medical Devices Co., Ltd.
- Manufacturing Company: Megadyne Medical Products Inc.
- Summary: The National Medical Products Administration (NMPA) announced a voluntary Class III recall of monopolar surgical electrodes manufactured by Megadyne Medical Products Inc. This action, reported by Shanghai Maisiqiang Medical Device Co., Ltd. on July 14, 2023, addresses a critical safety issue. The primary concern is the potential for liquid seepage within the product, which could lead to significant malfunctions during surgical procedures. Specifically, these malfunctions include intermittent activation, complete failure of the device to activate when intended, or, more dangerously, automatic and unintended activation. Such defects could pose serious risks to patient safety and surgical outcomes. Megadyne Medical Products Inc. is initiating this recall to remove all affected product models, specifications, and batches from circulation, as detailed in an accompanying Medical Device Recall Event Report Form. This voluntary recall is a proactive measure under the NMPA's regulatory framework, demonstrating the manufacturer's commitment to product safety and compliance with medical device standards. The required action involves retrieving the identified problematic devices to prevent further use and mitigate potential harm to patients.

Company: https://www.globalkeysolutions.net/companies/megadyne-medical-products-inc/5e1c6a60-8f96-496f-866f-b93b80c26a5c/