China NMPA Product Recall - Breathing tubing for anesthesia machines and ventilators

Hangzhou Jingling Medical Device Co., Ltd. initiated a voluntary Level III recall of its breathing tubing for anesthesia machines and ventilators, as reported on September 18, 2017, under the oversight of the National Medical Products Administration (NMPA). The recall was triggered by a manufacturing concern involving suspected glue overflow during the bonding of the product interface to the tubing preform. This defect could adversely affect the airflow resistance performance of the breathing tubing, potentially impacting patient safety. The recall specifically targets product model HX-01G 1.6m, impacting batches 44511704 and 44511706, with 750 sets produced and 704 sets sold in China. As part of the required corrective actions, the company must immediately issue a notice to cease the use and sale of the identified products, and recall all affected units that have been sold but remain unused. Additionally, Hangzhou Jingling Medical Device Co., Ltd. is mandated to improve its performance testing methods for airflow resistance and retest all returned products to ensure compliance and address the quality issue effectively.