# China NMPA Product Recall - Prismaflex system

Source: https://www.globalkeysolutions.net/records/china_product_recall/baxter-medical-supplies-trading-shanghai-co-ltd/316265cf-83fc-42bd-a3f2-9b8460aebbfa/
Source feed: China

> China NMPA product recall for Prismaflex system by Baxter Medical Supplies Trading (Shanghai) Co., Ltd. published February 24, 2021. Recall level: Level 2 Recall. Baxter Medical Products Trading (Shanghai) Co., Ltd. initiated a voluntary Level 2 recall for its Pr

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Baxter Medical Supplies Trading (Shanghai) Co., Ltd. is voluntarily recalling its continuous blood purification equipment, continuous blood purification devices, and continuous blood purification devices.
- Company Name: Baxter Medical Supplies Trading (Shanghai) Co., Ltd.
- Publication Date: 2021-02-24
- Product Name: Prismaflex system
- Recall Level: Level 2 Recall
- Recall Reason: There is an increasing trend of quality failures related to the Prismaflex automatic reset system pump tubing. This is due to performance degradation in the tubing within the pump, which may cause alarms during and after the system's self-check during pre-filling or treatment. Repeated alarms can trigger treatment interruptions, potentially causing harm to the patient.
- Discovering Company: Baxter Medical Supplies Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Baxter Medical Supplies Trading (Shanghai) Co., Ltd.
- Summary: Baxter Medical Products Trading (Shanghai) Co., Ltd. initiated a voluntary Level 2 recall for its Prismaflex Continuous Blood Purification Equipment and related devices, as announced by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration on February 24, 2021. The recall was prompted by an increasing trend of quality failures involving the pump tubing within the Prismaflex automatic reset system. This issue stems from performance degradation in the tubing, which can lead to alarms during the system's self-test or treatment. Repeated alarms pose a significant risk of treatment interruptions, potentially causing harm to patients. To address these critical safety concerns, Baxter is implementing a corrective action. This action includes the replacement of the affected pump tubing and a proactive recall of the devices to ensure patient safety and compliance with medical device regulations under the NMPA's framework.

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