# China NMPA Product Recall - Disposable laparoscopic pre-set chip cutting stapler cartridge

Source: https://www.globalkeysolutions.net/records/china_product_recall/covidien-llc/c5ea3ed8-4b90-4a4d-bab1-3bfa20393009/
Source feed: China

> China NMPA product recall for Disposable laparoscopic pre-set chip cutting stapler cartridge by Covidien llc published March 14, 2023. Recall level: Level 2 Recall. The National Medical Products Administration (NMPA) announced a Class II voluntary recall initiated 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Covidien LLC is voluntarily recalling disposable laparoscopic pre-embedded chip cutting stapler cartridges.
- Company Name: Covidien llc
- Publication Date: 2023-03-14
- Product Name: Disposable laparoscopic pre-set chip cutting stapler cartridge
- Recall Level: Level 2 Recall
- Recall Reason: Incomplete firing of the nail cartridge occurred in certain models and batches of products.
- Discovering Company: Covidien Medical Devices International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Covidien llc
- Summary: The National Medical Products Administration (NMPA) announced a Class II voluntary recall initiated by Covidien LLC for specific batches of its single-use laparoscopic pre-embedded chip cutting staple cartridges. This action, reported by Covidien Medical Devices International Trading (Shanghai) Co., Ltd., became publicly available on March 14, 2023. The fundamental issue prompting this recall is the incomplete firing of the staple cartridge, a critical functional defect identified in particular models and manufacturing batches of the device. Such a malfunction could compromise the effectiveness and safety of laparoscopic surgical procedures. Operating under the NMPA's regulatory oversight, Covidien LLC is undertaking this recall to address the product's non-conformance with expected performance standards. A Class II recall signifies that the product may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. The affected product is identified by National Medical Device Registration Certificate No. 20223010142. The company is required to remove the identified faulty devices from circulation, ensuring the safety of patients and healthcare providers. Further specifics regarding the impacted product models, specifications, and batch numbers are detailed in the "Medical Device Recall List" and an accompanying "Medical Device Recall Event Report Form," accessible via the NMPA's website. This action underscores a commitment to medical device quality and patient safety within the NMPA's framework.

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