# China NMPA Product Recall - Continuous blood purification equipment

Source: https://www.globalkeysolutions.net/records/china_product_recall/baxter-medical-supplies-trading-shanghai-co-ltd/07344a01-e727-4e60-a759-cd674b89c710/
Source feed: China

> China NMPA product recall for Continuous blood purification equipment by Baxter Medical Supplies Trading (Shanghai) Co., Ltd. published May 08, 2017. Recall level: Level III. Baxter Medical Supplies Trading (Shanghai) Co., Ltd. has initiated a voluntary Class III recall of i

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Baxter Medical Supplies Trading (Shanghai) Co., Ltd. voluntarily recalls continuous blood purification equipment.
- Company Name: Baxter Medical Supplies Trading (Shanghai) Co., Ltd.
- Publication Date: 2017-05-08
- Product Name: Continuous blood purification equipment
- Recall Level: Level III
- Recall Reason: Incidents of patient harm caused by failure to properly remove or install consumables according to the user manual and equipment screen prompts.
- Discovering Company: Baxter Medical Supplies Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Baxter Medical Supplies Trading (Shanghai) Co., Ltd.
- Summary: Baxter Medical Supplies Trading (Shanghai) Co., Ltd. has initiated a voluntary Class III recall of its Continuous Blood Purification Equipment. This action, reported to the National Medical Products Administration (NMPA) on May 8, 2017, follows reports from markets outside China concerning patient harm. The reported issues stemmed from the improper removal and installation of consumables, indicating a failure by users to adhere to the operational manual and equipment screen prompts.

There are no inspection dates specified in the provided document, as this is a company-initiated voluntary recall rather than a regulatory inspection outcome. The regulatory framework for this recall is governed by the NMPA, which oversees medical device recalls in China. A Class III recall typically addresses situations where the probability of serious adverse health consequences from product use is remote. The required action by Baxter is the recall of specific models, specifications, and batches of the Continuous Blood Purification Equipment, with detailed information found in the "Medical Device Recall Event Report Form." This highlights the importance of user compliance with device instructions for patient safety.

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