# China NMPA Product Recall - High-frequency electrosurgical system accessories

Source: https://www.globalkeysolutions.net/records/china_product_recall/covidien-llc/d8653bd0-e603-41a7-b046-4bc4a1bd3b0f/
Source feed: China

> China NMPA product recall for High-frequency electrosurgical system accessories by Covidien llc published March 18, 2019. Recall level: Level 2 Recall. Covidien LLC, with its agent Covidien Medical Devices International Trading (Shanghai) Co., Ltd., in

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Covidien LLC is proactively recalling accessories for its high-frequency electrosurgical system.
- Company Name: Covidien llc
- Publication Date: 2019-03-18
- Product Name: High-frequency electrosurgical system accessories
- Recall Level: Level 2 Recall
- Recall Reason: The reason for this voluntary recall is that our company has identified a possibility that the sterile packaging of certain batches of high-frequency electrosurgical system accessories may not be completely sealed. Using products with this problem may increase the risk of infection.
- Discovering Company: Covidien Medical Devices International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Covidien llc
- Summary: Covidien LLC, with its agent Covidien Medical Devices International Trading (Shanghai) Co., Ltd., initiated a voluntary Class II recall of accessories for its high-frequency electrosurgical system (NMPA Registration Certificate No. 20163251111). The recall was reported on March 8, 2019, and subsequently published by the National Medical Products Administration (NMPA) on March 18, 2019. The main issue prompting this action was the identified potential for incomplete sealing in the sterile packaging of specific batches of these accessories. This defect could compromise product sterility, thereby increasing the risk of infection for patients during surgical procedures. The affected product model is FT3000, with identified batch numbers like 80390309X. Under the regulatory framework communicated by the NMPA, the company took proactive steps to address this manufacturing concern. Notably, Covidien LLC confirmed that no affected products were sold within China, meaning no further corrective actions were required in that region. The company reported no complaints related to this issue globally at the time of the recall, highlighting a proactive approach to product safety and regulatory compliance.

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