# China NMPA Product Recall - Laparoscopic disposable stapler with curved staple cartridge

Source: https://www.globalkeysolutions.net/records/china_product_recall/covidien-llc/b4a16869-084f-4581-b3c8-2072cf3c2043/
Source feed: China

> China NMPA product recall for Laparoscopic disposable stapler with curved staple cartridge by Covidien llc published November 04, 2017. Recall level: Level 2 Recall. Covidienllc, a medical device manufacturer, initiated a voluntary Class II recall of its arc-shaped 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Covidienllc is proactively recalling its laparoscopic single-use stapler cartridge.
- Company Name: Covidien llc
- Publication Date: 2017-11-04
- Product Name: Laparoscopic disposable stapler with curved staple cartridge
- Recall Level: Level 2 Recall
- Recall Reason: The staple cartridge of a disposable laparoscopic stapler may become loose during use, potentially requiring removal of the dislodged material or resulting in incomplete staple formation and non-functional tissue anastomosis. This issue is attributed to manufacturing errors.
- Discovering Company: Covidien Medical Devices International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Covidien llc
- Summary: Covidienllc, a medical device manufacturer, initiated a voluntary Class II recall of its arc-shaped staple container for disposable endoscopic cutting staplers (Registration Certificate No.: 20153461467) through its agent, Covidien Medical Devices International Trading (Shanghai) Co., Ltd. The recall was reported to the National Medical Products Administration (NMPA) on September 29, 2017, and published on November 4, 2017. The primary issue prompting the recall was the potential for the staple cartridge to become loose during surgical use. This malfunction could necessitate the removal of detached components or lead to incomplete tissue anastomosis, posing risks to patient outcomes. The problem was identified following two global complaints and attributed to a manufacturing error affecting specific batches, including Batch Number N6L0351X, model EGIARADXT. The product, a laparoscopic disposable cutting and anastomosis device arc-shaped staple cartridge, is designed for various surgical procedures, including general, abdominal, obstetrics and gynecology, thoracic, and deep pelvic surgeries. The recall impacts regions such as Latin America, Europe, and Japan. Despite the identified issue, no patient injuries related to this specific problem have been reported by Medtronic (parent company of Covidien). The company's required action is the voluntary recall of the affected products.

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