# China NMPA Product Recall - Heart-Lung Circulation Heat Exchanger System

Source: https://www.globalkeysolutions.net/records/china_product_recall/lenofa-germany-gmbh/3dfbceb1-8469-4313-a771-9853762bcbfe/
Source feed: China

> China NMPA product recall for Heart-Lung Circulation Heat Exchanger System by Lenofa Germany GmbH published September 06, 2023. Recall level: Level 3 Recall. The National Medical Products Administration (NMPA) announced a Class III voluntary recall on Septem

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: LivaNova Deutschland GmbH has initiated a voluntary recall of its cardiopulmonary bypass heat exchange tanks.
- Company Name: Lenofa Germany GmbH
- Publication Date: 2023-09-06
- Product Name: Heart-Lung Circulation Heat Exchanger System
- Recall Level: Level 3 Recall
- Recall Reason: The maintenance calendar in the Quick Reference Guide (QRG) for some serial number products contains incorrect information.
- Discovering Company: Linova (China) Medical Technology Co., Ltd.
- Manufacturing Company: Lenofa Germany GmbH
- Summary: The National Medical Products Administration (NMPA) announced a Class III voluntary recall on September 6, 2023, initiated by manufacturer LivaNova Deutschland GmbH. This recall specifically targets certain Cardiopulmonary Heat Exchanger Tanks, identified as a Heater-Cooler System (National Medical Device Registration Certificate 20172102137). LivaNova (China) Medical Technology Co., Ltd. formally reported the issue, which involves incorrect information within the maintenance calendar of the Quick Reference Guide (QRG) for specific product serial numbers. This discrepancy could potentially lead to improper maintenance scheduling. The voluntary recall serves as a proactive measure by the manufacturer to rectify the erroneous information and uphold product safety and correct usage. Details regarding the affected product models, specifications, and serial numbers are provided in a supplementary Medical Device Recall Event Report Form. The NMPA oversees this regulatory action, ensuring adherence to medical device standards. This demonstrates the manufacturer's dedication to maintaining product integrity and user safety by correcting vital operational guidance.

Company: https://www.globalkeysolutions.net/companies/lenofa-germany-gmbh/7219ede1-b651-4a68-8455-31031e228b69/