# China NMPA Product Recall - Polyflux H hollow fiber dialysis filter

Source: https://www.globalkeysolutions.net/records/china_product_recall/gambro-dialysatoren-gmbh/b2f728ea-18be-480d-b90f-8f25dc09b4da/
Source feed: China

> China NMPA product recall for Polyflux H hollow fiber dialysis filter by Gambro Dialysatoren GmbH published June 09, 2021. Recall level: Level 2 Recall. On June 9, 2021, Gambro Dialysatoren GmbH, through its reporting entity Baxter Medical Supplies Trad

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Gambro Dialysatoren GmbH is voluntarily recalling its Polyflux H hollow fiber dialysis filter.
- Company Name: Gambro Dialysatoren GmbH
- Publication Date: 2021-06-09
- Product Name: Polyflux H hollow fiber dialysis filter
- Recall Level: Level 2 Recall
- Recall Reason: Because this involved specific models and batches of products, users discovered what appeared to be "particulate matter" in the products before use.
- Discovering Company: Baxter Medical Supplies Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Gambro Dialysatoren GmbH
- Summary: On June 9, 2021, Gambro Dialysatoren GmbH, through its reporting entity Baxter Medical Supplies Trading (Shanghai) Co., Ltd., initiated a voluntary Class II recall of its Polyflux H Hollow Fiber Dialysis Filter. This action was prompted by user reports of suspected "particulate matter" found within specific models and batches of the product prior to use. The affected products are registered under Certificate No.: 20153450504. This recall falls under the regulatory framework of the National Medical Products Administration (NMPA) in China, which published the official notification. While the document does not specify inspection dates, the recall was a direct response to these pre-use observations, indicating a potential quality control issue. A Class II recall signifies that the use of or exposure to the recalled product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Gambro Dialysatoren GmbH is undertaking proactive measures to remove the affected products from circulation, demonstrating adherence to regulatory standards and a commitment to patient safety. Further details regarding the specific models and batches are available in the accompanying "Medical Device Recall List."

Company: https://www.globalkeysolutions.net/companies/gambro-dialysatoren-gmbh/5cf8f7b2-b364-438d-b1a1-3a0cb277c731/