China NMPA Product Recall - Hollow fiber hemodialysis machine

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.