# 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/20cac4e0-cbd2-43d7-b980-491254293c5e/
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 February 24, 2020. Recall level: Level 2 Recall. On February 24, 2020, Baxter Medical Products Trading (Shanghai) Co., Ltd. initiated a voluntary Cla

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Baxter Medical Supplies Trading (Shanghai) Co., Ltd. is voluntarily recalling continuous blood purification devices (continuous blood purification equipment).
- Company Name: Baxter Medical Supplies Trading (Shanghai) Co., Ltd.
- Publication Date: 2020-02-24
- Product Name: Continuous blood purification device; continuous blood purification equipment
- Recall Level: Level 2 Recall
- Recall Reason: In relation to the product in question, Baxter hereby issues a safety warning, reiterating its reminder to customers to strictly adhere to the Prismaflex operating manual for safe operation. Inserting third-party connectors or connecting lines between the Prismaflex infusion line and the patient's vascular access may pose safety risks. Failure to follow the Prismaflex operating manual may result in the control unit being unable to properly monitor pressure drops in the extracorporeal circulation line, posing a potential risk of blood loss.
- Discovering Company: Baxter Medical Supplies Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Baxter Medical Supplies Trading (Shanghai) Co., Ltd.
- Summary: On February 24, 2020, Baxter Medical Products Trading (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its continuous blood purification devices, specifically the Prismaflex Continuous Blood Purification Equipment (CFDA Import Registration Nos. 20113453455 and 20163451912). This action, reported by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration, addresses a significant safety concern. The primary issue stems from the potential for blood loss if the Prismaflex operating manual is not strictly adhered to. The company issued a safety warning after identifying that inserting a third-party connector or additional tubing between the infusion line and the patient's vascular access could compromise the device's functionality. When the manual's instructions are not followed, the control unit may fail to accurately monitor the pressure drop within the extracorporeal circulation tubing, leading to a risk of blood loss for patients. In response, Baxter Medical Products Trading (Shanghai) Co., Ltd. undertook this voluntary recall to mitigate potential risks. The required actions involve recalling affected product models, specifications, and batches, with detailed information available in a "Medical Device Recall Event Report Form." Furthermore, the company reinforced its safety warning, urging all customers to operate the Prismaflex system strictly according to the provided instructions to ensure patient safety and device efficacy.

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