China NMPA Product Recall - Peritoneal dialysis machine tubing

Baxter Medical Supplies Trading (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its peritoneal dialysis machine tubing, as announced on August 1, 2019, under the oversight of the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration. The recall stems from a critical manufacturing issue identified during the production process. Specifically, a misalignment between the welding mold and the Luer gripper in certain batches of the patient-end tubing created a potential leakage risk. While no serious injuries have been reported in connection with this issue, the company proactively decided to remove the affected products from the market. The recall covers peritoneal dialysis machine tubing with Registration Certificate No.: 20172451708. Detailed information, including specific models, specifications, and batch numbers, is available in the "Medical Device Recall Event Report Form." This action ensures compliance with medical device safety standards and prioritizes patient well-being by addressing a critical product deficiency.