# China NMPA Product Recall - Disposable hemodialysis filters and tubing

Source: https://www.globalkeysolutions.net/records/china_product_recall/baxter-medical-supplies-trading-shanghai-co-ltd/da00884d-6320-4c51-b340-3e08b42dd653/
Source feed: China

> China NMPA product recall for Disposable hemodialysis filters and tubing by Baxter Medical Supplies Trading (Shanghai) Co., Ltd. published January 17, 2019. Recall level: Level 2 Recall. On January 17, 2019, Baxter Medical Supplies Trading (Shanghai) Co., Ltd. initiated a voluntary Leve

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Baxter Medical Supplies Trading (Shanghai) Co., Ltd. is voluntarily recalling disposable hemodialysis filters and related tubing.
- Company Name: Baxter Medical Supplies Trading (Shanghai) Co., Ltd.
- Publication Date: 2019-01-17
- Product Name: Disposable hemodialysis filters and tubing
- Recall Level: Level 2 Recall
- Recall Reason: The product in question has a problem where the blood pump tubing is too long, preventing consumables from being fully installed on the machine or leaving the blood pump in a non-sealed state. This ultimately leads to consumable pre-charging failure, machine alarms, and requires medical staff to replace the consumables with qualified ones for the continuous blood purification device to operate normally.
- Discovering Company: Baxter Medical Supplies Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Baxter Medical Supplies Trading (Shanghai) Co., Ltd.
- Summary: On January 17, 2019, Baxter Medical Supplies Trading (Shanghai) Co., Ltd. initiated a voluntary Level II recall for its disposable hemodialysis filters and connecting tubing. This action was undertaken in accordance with the regulatory framework set by China's National Medical Products Administration (NMPA). The recall stemmed from critical product deficiencies that impacted the functionality of continuous blood purification devices. Issues identified included excessively long blood pump tubing, which prevented consumables from being fully installed on the machine, and a non-sealed state of the blood pump. These manufacturing deviations led to operational failures such as consumable pre-charging failures and machine alarms, necessitating medical staff to replace the faulty components with qualified consumables to ensure proper device operation. Detailed information on affected product models, specifications, and batches was made available in a Medical Device Recall Event Report Form.

Company: https://www.globalkeysolutions.net/companies/baxter-medical-supplies-trading-shanghai-co-ltd/6683d881-f097-4ad4-8c0e-86927dfa203a/