China NMPA Product Recall - Disposable dialysis blood circuit tubing

Jiangsu Fresenius Medical Supplies Co., Ltd. has initiated a voluntary Level 3 recall of its disposable dialysis blood circuit tubes, model AP16641 / AV-Set 4008H. This action, reported to the National Medical Products Administration (NMPA) on October 9, 2017, addresses a critical quality issue: a potential closure problem with small clamps on the tubing. Specifically, clamps located at the arterial and venous tubing's rear pump position and the T-connector's front pump position may fail to close properly, potentially leading to leakage during hemodialysis treatment.

The recall encompasses 269 batches, totaling over 5 million sets manufactured between February 1, 2017, and July 24, 2017. More than 4.2 million of these sets were distributed in China, with additional affected regions including the Philippines, Thailand, Vietnam, Malaysia, and Singapore.

In response to this concern, Jiangsu Fresenius Medical Supplies has mandated specific corrective actions. User facilities are instructed to immediately cease using all affected product batches. All existing inventory of the recalled products must be returned to the company for processing. Returned products will be managed through sorting or rework, adhering to an approved disposal plan. This recall highlights the company's commitment to patient safety under NMPA regulatory oversight.