# China NMPA Product Recall - Hemodialysis water treatment system

Source: https://www.globalkeysolutions.net/records/china_product_recall/b-braun-shanghai-trading-co-ltd/fa5e5212-18f5-47c3-ad0b-691c00e372be/
Source feed: China

> China NMPA product recall for Hemodialysis water treatment system by B. Braun (Shanghai) Trading Co., Ltd. published May 29, 2019. Recall level: Level 3 Recall. B. Braun (Shanghai) Trading Co., Ltd. initiated a voluntary Class III recall of its hemodialysis wat

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: B. Braun (Shanghai) Trading Co., Ltd. is voluntarily recalling its hemodialysis water treatment system.
- Company Name: B. Braun (Shanghai) Trading Co., Ltd.
- Publication Date: 2019-05-29
- Product Name: Hemodialysis water treatment system
- Recall Level: Level 3 Recall
- Recall Reason: Product label printing error
- Discovering Company: B. Braun (Shanghai) Trading Co., Ltd.
- Manufacturing Company: B. Braun (Shanghai) Trading Co., Ltd.
- Summary: B. Braun (Shanghai) Trading Co., Ltd. initiated a voluntary Class III recall of its hemodialysis water treatment system, identified by Registration Certificate No.: 20182102622. This action, published on May 29, 2019, was prompted by a printing error discovered on the product label. The recall event was reported through the Shanghai Food and Drug Administration Medical Device Recall 2019-120 and is overseen by the National Medical Products Administration (NMPA). While no specific inspection dates were provided, the recall itself serves as a corrective measure under the regulatory framework of medical device oversight in China. A printing error on a medical device label, even if minor, necessitates a recall to ensure accuracy of product information, proper usage, and patient safety, aligning with established quality control and regulatory compliance standards for medical devices. The company is required to provide detailed information on affected models, specifications, and batch numbers through a Medical Device Recall Event Report Form.

Company: https://www.globalkeysolutions.net/companies/b-braun-shanghai-trading-co-ltd/7b7e0eb3-f424-4c86-9999-2254073ca54e/