# China NMPA Product Recall - Hemodialysis machine

Source: https://www.globalkeysolutions.net/records/china_product_recall/bellco-sil/b2000aaf-3e88-48de-9e6e-b00b1aa86583/
Source feed: China

> China NMPA product recall for Hemodialysis machine by Bellco Sil. published March 01, 2017. Recall level: Level III. Beierke Hexiang Medical Equipment (Shanghai) Co., Ltd. initiated a voluntary Level III recall of its

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beierke Hexiang Medical Equipment (Shanghai) Co., Ltd. voluntarily recalls hemodialysis machines
- Company Name: Bellco Sil.
- Publication Date: 2017-03-01
- Product Name: Hemodialysis machine
- Recall Level: Level III
- Recall Reason: The Chinese label registration certificate number is incorrect.
- Discovering Company: Beierke Hexiang Medical Equipment (Shanghai) Co., Ltd.
- Manufacturing Company: Bellco Sil.
- Summary: Beierke Hexiang Medical Equipment (Shanghai) Co., Ltd. initiated a voluntary Level III recall of its Hemodialyzers (Model/Specification: BLS816SD, Batch LOT.1609000117) due to an incorrect registration certificate number printed on the product's Chinese label. This issue was self-identified by the company, which reported the event on January 13, 2017, leading to a public notification by the National Medical Products Administration (NMPA) on March 1, 2017.
The affected products, totaling 3360 units imported into China, were distributed in regions including Suzhou, Shanghai, and Guangzhou. The Hemodialyzers are designed for single-use blood filtration, hemodialysis, and hemodiafiltration to correct solute and fluid imbalances in patients.
Under the NMPA's regulatory framework for medical device recalls, Beierke Hexiang Medical Equipment outlined specific corrective actions. These include instructing sales teams and distributors to notify affected customers, requiring customers and distributors to return the mislabeled batch of dialyzers to the company. Subsequently, the company's warehouse is responsible for replacing the returned products with correctly labeled units, ensuring compliance and patient safety. This recall demonstrates the company's commitment to correcting labeling discrepancies in accordance with regulatory standards.

Company: https://www.globalkeysolutions.net/companies/bellco-sil/67343562-a5b5-4149-affe-79c9bb0eb3bc/