# China NMPA Product Recall - Hollow fiber hemodialysis machine

Source: https://www.globalkeysolutions.net/records/china_product_recall/bestar-medical-equipment-guangzhou-co-ltd/e22ab330-6826-45c0-a148-f443a60fed0d/
Source feed: China

> China NMPA product recall for Hollow fiber hemodialysis machine by Bestar Medical Equipment (Guangzhou) Co., Ltd. published October 24, 2018. Recall level: Level 3 Recall. Bain & Company Medical Devices (Guangzhou) Co., Ltd. initiated a voluntary Level 3 recall of its Hol

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Bain Medical Equipment (Guangzhou) Co., Ltd. voluntarily recalls hollow fiber hemodialysis machines
- Company Name: Bestar Medical Equipment (Guangzhou) Co., Ltd.
- Publication Date: 2018-10-24
- Product Name: Hollow fiber hemodialysis machine
- Recall Level: Level 3 Recall
- Recall Reason: Our company has been informed that the above batches of products failed the vitamin B12 clearance tests for QD 500mL/min, QF-10mL/min, and QB-200mL/min, and for QD 500mL/min, QF-10mL/min, and QB-300mL/min. Patients using this batch of products may experience inadequate dialysis treatment. To date, our company has not received any reports of related adverse events. However, to avoid potential risks, the manufacturer has initiated a voluntary recall.
- Discovering Company: Bain Medical Equipment (Guangzhou) Co., Ltd.
- Manufacturing Company: Bestar Medical Equipment (Guangzhou) Co., Ltd.
- Summary: Bain & Company Medical Devices (Guangzhou) Co., Ltd. initiated a voluntary Level 3 recall of its Hollow Fiber Hemodialyzers (Model B-18H, batch 1703210957) in October 2018, as reported by the National Medical Products Administration (NMPA). The recall stemmed from product testing indicating the hemodialyzers failed to meet standard requirements for vitamin B12 clearance rates under specific flow conditions. This deficiency could potentially lead to inadequate dialysis treatment for patients with acute and chronic renal failure.
The company stated that its internal factory inspection reports showed the products were compliant. However, in response to the test results, Bain & Company Medical Devices applied for a re-inspection on September 5, 2018. Out of 530 units produced in the affected batch, 504 units were distributed and sold in China. Although no adverse events related to the defect had been reported at the time of the recall, the company opted for a recall to mitigate potential patient risks.
As a required action, affected distributors and hospitals were instructed to immediately suspend sales and use of the specific batch of hemodialyzers, pending the outcome of the re-inspection. The recall ensures adherence to medical device safety standards under the NMPA's regulatory oversight.

Company: https://www.globalkeysolutions.net/companies/bestar-medical-equipment-guangzhou-co-ltd/8ae3d8ae-14cf-4c33-bace-c9482add5131/