China NMPA Product Recall - Breathing tubing, nasal mask, nasal pillow

ResMed Limited, an Australian medical device manufacturer, initiated a voluntary Level 3 recall in China for specific breathing tubes, nasal masks, and nasal pillows. This action, reported on April 19, 2019, involved 4487 units across 25 batches, including ClimateLine MAX Oxy, AirFit N10, and AirFit P10 series, handled by its agent Kaiditai (Beijing) Medical Technology Co., Ltd. The core issue, identified under the National Medical Products Administration (NMPA) regulatory framework, was a discrepancy in the product registration. The Chinese registration certificate failed to include ResMed Asia Operations Pty Ltd. (Singapore) as a contract manufacturing site, rendering the products inconsistent with their official registration details. Despite this regulatory non-compliance, ResMed affirmed that the products met all specifications, were free of manufacturing defects, and were produced under qualified conditions, ensuring their safety for use. Required actions include notifying distributors, replacing unopened affected products, and facilitating the return of all impacted items to ResMed (Beijing) Medical Technology Co., Ltd., for subsequent assessment regarding re-inventory or destruction.