# China NMPA Product Recall - Hollow fiber dialyzer/hemodialysis filter

Source: https://www.globalkeysolutions.net/records/china_product_recall/nipro-medical-devices-hefei-co-ltd/013d7411-dcb8-44c7-b1a7-db58b3f9084b/
Source feed: China

> China NMPA product recall for Hollow fiber dialyzer/hemodialysis filter by Nipro Medical Devices (Hefei) Co., Ltd. published June 28, 2022. Recall level: Level 2 Recall. Nipro Medical Devices (Hefei) Co., Ltd. initiated a voluntary Class II recall of its hollow fiber di

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Nipro Medical Devices (Hefei) Co., Ltd. is voluntarily recalling hollow fiber dialyzers/hemodialysis filters.
- Company Name: Nipro Medical Devices (Hefei) Co., Ltd.
- Publication Date: 2022-06-28
- Product Name: Hollow fiber dialyzer/hemodialysis filter
- Recall Level: Level 2 Recall
- Recall Reason: The product has an abnormal risk of bleeding from membrane rupture.
- Discovering Company: Nipro Medical Devices (Hefei) Co., Ltd.
- Manufacturing Company: Nipro Medical Devices (Hefei) Co., Ltd.
- Summary: Nipro Medical Devices (Hefei) Co., Ltd. initiated a voluntary Class II recall of its hollow fiber dialyzers and hemodialysis filters, as announced by the National Medical Products Administration (NMPA) on June 28, 2022. The recall stems from an identified abnormal risk of membrane rupture and leakage in these critical medical devices. The affected products include those under Registration Certificate No. 20173103117 and National Medical Device Registration Certificate No. 20203100611. While the document does not specify inspection dates, the company proactively reported the issue and commenced the recall to ensure patient safety. Details regarding the specific models, specifications, and batch numbers involved in this action are provided in an attached Medical Device Recall Event Report Form. This voluntary recall demonstrates the company's commitment to regulatory compliance and patient welfare under the NMPA's oversight.

Company: https://www.globalkeysolutions.net/companies/nipro-medical-devices-hefei-co-ltd/ca4f1c5e-9e91-45cd-8cbf-ef1144659d47/