# China NMPA Product Recall - Hemodialysis filter

Source: https://www.globalkeysolutions.net/records/china_product_recall/beierke-hexiang-medical-equipment-shanghai-co-ltd/5c790af9-b733-4960-b359-9d7ab903c467/
Source feed: China

> China NMPA product recall for Hemodialysis filter by Beierke Hexiang Medical Equipment (Shanghai) Co., Ltd. published December 05, 2018. Recall level: Level 3. Bellerek Hexiang Medical Equipment (Shanghai) Co., Ltd. initiated a voluntary Class III recall of it

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beierke Hexiang Medical Equipment (Shanghai) Co., Ltd. voluntarily recalls hemodialysis filters
- Company Name: Beierke Hexiang Medical Equipment (Shanghai) Co., Ltd.
- Publication Date: 2018-12-05
- Product Name: Hemodialysis filter
- Recall Level: Level 3
- Recall Reason: The product in question was found during a random inspection of medical devices to have an in vitro vitamin B12 measurement exceeding the tolerance range of ±10%.
- Discovering Company: Beierke Hexiang Medical Equipment (Shanghai) Co., Ltd.
- Manufacturing Company: Beierke Hexiang Medical Equipment (Shanghai) Co., Ltd.
- Summary: Bellerek Hexiang Medical Equipment (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its hemodialysis filters (Registration Certificate No.: CFDA (Imported) 2014 No. 3451955 (Revised)). This action followed a medical device sampling inspection where in vitro test results revealed a critical quality issue: the measured value of Vitamin B12 in the filters exceeded the acceptable tolerance range of 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Company: https://www.globalkeysolutions.net/companies/beierke-hexiang-medical-equipment-shanghai-co-ltd/2cf5ee8b-11a4-45f4-a8c3-48f8f41e57c2/