# China NMPA Product Recall - Hemodialysis, hemodiafiltration device

Source: https://www.globalkeysolutions.net/records/china_product_recall/b-braun-shanghai-trading-co-ltd/84c5d133-925d-45c5-9bbe-e7d86c1b1567/
Source feed: China

> China NMPA product recall for Hemodialysis, hemodiafiltration device by B. Braun (Shanghai) Trading Co., Ltd. published March 19, 2021. Recall level: Level 3. B. Braun (Shanghai) Trading Co., Ltd. initiated a voluntary Class III recall of its hemodialysis dev

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: B. Braun (Shanghai) Trading Co., Ltd. is voluntarily recalling hemodialysis equipment and hemodialysis filtration devices.
- Company Name: B. Braun (Shanghai) Trading Co., Ltd.
- Publication Date: 2021-03-19
- Product Name: Hemodialysis, hemodiafiltration device
- Recall Level: Level 3
- Recall Reason: The product in question has a missing screw washer located between the screw head and the plastic gasket at the bottom of the heparin pump. This missing washer may cause the screws under the heparin pump and the heparin pump itself to loosen during use, resulting in a reduction in heparin delivery volume of up to 10% of the syringe volume. However, it will not cause an increase in heparin delivery volume.
- 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 devices and hemodialysis filtration devices, specifically affecting heparin pump products. The recall, indexed by the National Medical Products Administration (NMPA) under reference JGXX-2021-10125 and published on March 19, 2021, addresses a critical manufacturing defect. The primary issue identified is a missing screw washer situated between the screw head and the plastic gasket at the bottom of the heparin pump. This omission could lead to the loosening of screws and the pump mechanism itself during operational use. Such loosening presents a significant risk of reduced heparin delivery volume, potentially decreasing by up to 10% of the syringe volume, which could impact patient treatment efficacy. As a required action, B. Braun (Shanghai) Trading Co., Ltd. is recalling all affected hemodialysis and hemodialysis filtration devices, identified by Registration Certificate No.: 20173450590. The company provided a "Medical Device Recall Report Form" with detailed information on affected models, specifications, and batches. This voluntary recall aims to mitigate the identified safety risk associated with the faulty components.

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