# China NMPA Product Recall - Continuous blood purification device; continuous blood purification equipment

Source: https://www.globalkeysolutions.net/records/china_product_recall/baxter-medical-supplies-trading-shanghai-co-ltd/1877410e-677d-4625-9320-6178f1a145f1/
Source feed: China

> China NMPA product recall for Continuous blood purification device; continuous blood purification equipment by Baxter Medical Supplies Trading (Shanghai) Co., Ltd. published April 10, 2021. Recall level: Level 2 Recall. On April 10, 2021, Baxter Medical Products Trading (Shanghai) Co., Ltd. initiated a voluntary Class 

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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 devices, equipment, and related products.
- Company Name: Baxter Medical Supplies Trading (Shanghai) Co., Ltd.
- Publication Date: 2021-04-10
- Product Name: Continuous blood purification device; continuous blood purification equipment
- Recall Level: Level 2 Recall
- Recall Reason: According to the Prismaflex user manual, using non-Baxter-compatible calcium infusion tubing for "citrate-syringe pump calcium infusion" anticoagulation may result in alarms such as "calcium infusion tubing not connected." Additionally, the PrismaLung function is not described in the user manual released in China, but it has been found to be enabled on some users' machines.
- Discovering Company: Baxter Medical Supplies Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Baxter Medical Supplies Trading (Shanghai) Co., Ltd.
- Summary: On April 10, 2021, Baxter Medical Products Trading (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its continuously circulating blood purification devices and associated equipment. This action, reported through the Shanghai Municipal Drug Administration and overseen by the National Medical Products Administration (NMPA), addresses two critical issues. The first concern involves potential operational alarms, such as "calcium infusion tubing not connected," if non-Baxter-compatible calcium infusion tubing is used for "citric acid-injector pump calcium infusion" anticoagulation. Users are directed to strictly follow the Prismaflex operating manual for proper connections. The second issue highlights a discrepancy where the PrismaLung function, found enabled on some user machines, is not described in the user manual distributed in China, indicating a significant documentation gap regarding an active device feature. The recall encompasses specific models, specifications, and batches, with details provided in the Medical Device Recall Event Report Form, underscoring the company's commitment to ensuring device safety and regulatory compliance.

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