# China NMPA Product Recall - Continuous blood purification equipment and devices

Source: https://www.globalkeysolutions.net/records/china_product_recall/baxter-medical-supplies-trading-shanghai-co-ltd/47ac8933-c1b0-4975-a26a-1b6656698c98/
Source feed: China

> China NMPA product recall for Continuous blood purification equipment and devices by Baxter Medical Supplies Trading (Shanghai) Co., Ltd. published November 27, 2019. Recall level: Level 2 Recall. Baxter Medical Products Trading (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its c

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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 and devices.
- Company Name: Baxter Medical Supplies Trading (Shanghai) Co., Ltd.
- Publication Date: 2019-11-27
- Product Name: Continuous blood purification equipment and devices
- Recall Level: Level 2 Recall
- Recall Reason: Globally, Baxter received customer reports of communication error alerts, averaging 1.4 alerts per 1,000 treatment regimens. Additionally, Baxter received three adverse event reports in overseas markets where patients experienced anemia and low blood pressure due to clinicians failing to promptly follow on-screen instructions to return blood after a communication error alert, requiring medical intervention.
- 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 Class II recall for its continuous blood purification equipment and devices, as reported by the National Medical Products Administration (NMPA) on November 27, 2019. The recall was prompted by customer reports of communication error alarms, occurring at a rate of 1.4 per 1000 treatment protocols globally. These technical malfunctions led to three reported adverse events in overseas markets. In these instances, clinicians did not promptly follow on-screen instructions to return blood to patients after an alarm, resulting in patients experiencing serious symptoms such as anemia and hypotension, which required medical intervention. The action, overseen by the Shanghai Municipal Drug Administration, underscores a commitment to addressing product performance issues that could impact patient safety. Detailed information regarding the affected product models, specifications, and batches is provided in the associated "Medical Device Recall Event Report Form" to facilitate proper management of the recall.

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