# China NMPA Product Recall - Disposable blunt-tipped closed surgical instrument, LigaSure Blunt Tip Laparoscopic Sealer/Divider Nano-coated

Source: https://www.globalkeysolutions.net/records/china_product_recall/covidien-llc/78589326-2d4d-4680-8047-05bbb2500af0/
Source feed: China

> China NMPA product recall for Disposable blunt-tipped closed surgical instrument, LigaSure Blunt Tip Laparoscopic Sealer/Divider Nano-coated by Covidien llc published July 18, 2022. Recall level: Level 2 Recall. On July 18, 2022, Covidien LLC, in collaboration with its subsidiary Covidien Medical Devices Intern

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Covidien LLC is voluntarily recalling the single-use blunt-tipped closed surgical instrument, LigaSure Blunt Tip Laparoscopic Sealer/Divider Nano-coated.
- Company Name: Covidien llc
- Publication Date: 2022-07-18
- Product Name: Disposable blunt-tipped closed surgical instrument, LigaSure Blunt Tip Laparoscopic Sealer/Divider Nano-coated
- Recall Level: Level 2 Recall
- Recall Reason: There are problems such as the jaws being difficult to open, the jaws easily getting stuck, and the jaws being unable to release tissue after gripping it.
- Discovering Company: Covidien Medical Devices International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Covidien llc
- Summary: On July 18, 2022, Covidien LLC, in collaboration with its subsidiary Covidien Medical Devices International Trading (Shanghai) Co., Ltd., initiated a voluntary Class II recall under the oversight of the National Medical Products Administration (NMPA). This significant action addresses critical functional deficiencies identified in specific models and batches of their Disposable Blunt-Tip Laparoscopic Sealer/Divider Nano-coated Surgical Instruments (Registration Certificate No.: 201930101). The core problems reported involve the instruments' jaws: users have encountered difficulty in opening them, a tendency for them to jam unexpectedly, and, critically, an inability to release tissue once clamped. Such malfunctions during surgical procedures could potentially lead to complications, extending operative times or causing unintended tissue damage, thereby posing risks to patient safety. The company is systematically recalling all affected products, with comprehensive details regarding specific models, specifications, and batches provided in the official "Medical Device Recall Event Report Form." This proactive measure underscores the commitment to product quality and patient well-being, ensuring compliance with established medical device standards.

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