# China NMPA Product Recall - Hernia repair device

Source: https://www.globalkeysolutions.net/records/china_product_recall/covidien-llc/ccd64129-b2ae-4009-b30c-f9bde001699b/
Source feed: China

> China NMPA product recall for Hernia repair device by Covidien llc published May 19, 2020. Recall level: Level 3 Recall. On May 19, 2020, the National Medical Products Administration (NMPA) in China announced a voluntary 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Covidien LLC initiates recall of hernia repair devices.
- Company Name: Covidien llc
- Publication Date: 2020-05-19
- Product Name: Hernia repair device
- Recall Level: Level 3 Recall
- Recall Reason: Certain product models and batches may have manufacturing or assembly errors, leading to operational failures during use.
- Discovering Company: Covidien Medical Devices Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Covidien llc
- Summary: On May 19, 2020, the National Medical Products Administration (NMPA) in China announced a voluntary recall initiated by Covidien LLC, a medical device manufacturer. This action was reported by Covidien Medical Devices Trading (Shanghai) Co., Ltd. The recall pertains to specific models and batches of hernia repair devices due to potential manufacturing and assembly errors. These identified errors could lead to operational failures of the devices during clinical use, posing a safety concern. The recall is classified as Level III, indicating that the use of or exposure to the affected product is not likely to cause adverse health consequences. While the NMPA published this announcement in 2020, the recall itself references a China Food and Drug Administration (CFDA) identification from 2011, suggesting it may be a revised or ongoing recall. Covidien LLC is implementing this voluntary action to address the product deficiencies. Further detailed information regarding the affected product models, specifications, and batch numbers is available in an attached "Medical Device Recall Event Report Form," overseen by the NMPA's regulatory framework to ensure medical device safety and quality in China.

Company: https://www.globalkeysolutions.net/companies/covidien-llc/5111c5da-0a3d-4895-b59e-e49f0ad3547d/