# China NMPA Product Recall - Continuous blood purification equipment

Source: https://www.globalkeysolutions.net/records/china_product_recall/infomed-s-a/f2eb595f-ccd0-4e84-9a1e-4c1e38b2239a/
Source feed: China

> China NMPA product recall for Continuous blood purification equipment by Infomed S. A. published October 24, 2018. Recall level: Level 3. Guangzhou Delang Medical Equipment Co., Ltd. has initiated a voluntary Level 3 recall for its Contin

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Guangzhou Delang Medical Equipment Co., Ltd. voluntarily recalls continuous blood purification equipment.
- Company Name: Infomed S. A.
- Publication Date: 2018-10-24
- Product Name: Continuous blood purification equipment
- Recall Level: Level 3
- Recall Reason: Our company has been informed that the above batch of models had the following issues during random inspection: 1. Venous pressure: According to YY 0645-2008, 5.6.1.3, under treatment mode, the low-limit alarm setting value must not be lower than 1.3 kPa (10 mmHg), which does not meet the requirements; Venous pressure: According to YZB/SWI 3166-2015, 4.6.2C, the low-limit alarm setting value must not be lower than 1.3 kPa (10 mmHg), which does not meet the requirements. 2. GB9706.1-2007 Medical Electrical Equipment Part 1: General Requirements for Safety 6.1 External Markings of Equipment or Equipment Components 1) Application Part Protection Against Electric Shock Symbols: B, BF, CF, which do not meet the requirements. This batch of products was not sold, and no related adverse event reports have been received.
- Discovering Company: Guangzhou Delang Medical Equipment Co., Ltd.
- Manufacturing Company: Infomed S. A.
- Summary: Guangzhou Delang Medical Equipment Co., Ltd. has initiated a voluntary Level 3 recall for its Continuous Blood Purification Equipment, as announced by the National Medical Products Administration (NMPA) on October 24, 2018. The recall stems from issues identified during random inspections, reported on September 27, 2008.

The main violations include the equipment's low-limit alarm setting value, which failed to meet the specified 1.3 kPa (10 mmHg) minimum required by YY 0645-2008 and YZB/SWI 3166-2015 for continuous blood purification. Additionally, the external marking for electric shock protection symbols (B, BF, CF) was non-compliant with GB9706.1-2007, a key safety standard for medical electrical equipment.

Only one unit from the affected batch was inspected and found non-compliant, with three additional units in company stock exhibiting similar labeling issues. None of these products were sold, and no related adverse event reports have been received. Guangzhou Delang has sealed all four non-compliant devices. The manufacturer, Infomed S.A., is sending engineers to replace the faulty labels. Post-replacement, the equipment will undergo re-testing at the Guangzhou Medical Device Quality Supervision and Inspection Center to ensure full compliance with regulatory standards.

Company: https://www.globalkeysolutions.net/companies/infomed-s-a/c1674d0e-7ebc-4f62-a9d0-eb77db1798e3/