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

Hangzhou Jingling Medical Device Co., Ltd. has initiated a voluntary Level III recall of its breathing tubing for anesthesia machines and ventilators. The recall, reported on September 18, 2017, and publicly announced by the National Medical Products Administration (NMPA) on November 13, 2017, pertains to product models HX-01G 1.6m with specific batch numbers 44511704 and 44511706, affecting 750 manufactured units, with 704 sold in China. The primary issue identified is suspected glue overflow during the bonding process of the product interface to the tubing. This manufacturing defect raises concerns that the airflow resistance performance of the breathing tubing may be compromised, potentially impacting patient safety when used with anesthesia machines, ventilators, humidifiers, and nebulizers. As part of the corrective actions, Hangzhou Jingling Medical Device Co., Ltd. has mandated that all distributors and users immediately cease the use and sale of the affected products. A recall is underway for all units already sold but not yet utilized. Furthermore, the company is required to enhance its performance testing methods for airflow resistance and retest all returned products to ensure compliance and address the identified defect. This action falls under the regulatory oversight of the NMPA, ensuring medical device safety standards are maintained.