# China NMPA Product Recall - Disposable laparoscopic trocar

Source: https://www.globalkeysolutions.net/records/china_product_recall/schaeder-xiamen-medical-equipment-co-ltd/c3cbaeb9-3cc9-4fe4-8cc4-9a459a9b2bed/
Source feed: China

> China NMPA product recall for Disposable laparoscopic trocar by Schaeder (Xiamen) Medical Equipment Co., Ltd. published December 17, 2019. Recall level: Level 3 Recall. Shiaide (Xiamen) Medical Equipment Co., Ltd. has initiated a voluntary Class III recall of its dispo

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Schiai (Xiamen) Medical Equipment Co., Ltd. has initiated a voluntary recall of disposable laparoscopic trocars.
- Company Name: Schaeder (Xiamen) Medical Equipment Co., Ltd.
- Publication Date: 2019-12-17
- Product Name: Disposable laparoscopic trocar
- Recall Level: Level 3 Recall
- Recall Reason: The "sealing and air resistance" indicators of the disposable laparoscopic trocar did not meet the requirements.
- Discovering Company: Schaeder (Xiamen) Medical Equipment Co., Ltd.
- Manufacturing Company: Schaeder (Xiamen) Medical Equipment Co., Ltd.
- Summary: Shiaide (Xiamen) Medical Equipment Co., Ltd. has initiated a voluntary Class III recall of its disposable laparoscopic puncture devices. This action follows a national medical device supervision and spot check, which identified a critical issue with the product. Specifically, the devices failed to meet the required "sealing and gas barrier" indicators. This non-conformance is significant as it directly impacts the functionality and safety of the devices, which are essential for maintaining a sterile and controlled environment during laparoscopic procedures.
The recall, overseen by the National Medical Products Administration (NMPA), aims to address these quality deficiencies and ensure patient safety. While specific inspection dates are not detailed, the recall was publicly announced on December 17, 2019, stemming from findings during national supervision activities. The company's prompt, voluntary recall demonstrates adherence to regulatory responsibilities under the NMPA framework. A Class III recall indicates that the product defect is unlikely to cause adverse health consequences but still warrants corrective action to prevent potential future issues. Detailed information regarding affected models, specifications, and batch numbers is available in the "Medical Device Recall Event Report Form," enabling identification and return of affected devices.

Company: https://www.globalkeysolutions.net/companies/schaeder-xiamen-medical-equipment-co-ltd/2b1b0220-aa92-42c9-99b8-849f01d33f53/