China NMPA Product Recall - septal puncture needle

Meriton Medical Devices, Inc. (USA), in conjunction with its Beijing subsidiary, Meriton Medical Devices (Beijing) Co., Ltd., announced a voluntary Class II recall of certain models and batches of its atrial septal puncture needles on February 7, 2021. This action was initiated due to a critical discrepancy found between the marked needle tip curvature and the actual curvature of the devices. The National Medical Products Administration (NMPA) of China is overseeing this recall, classifying it as a Class II event, which indicates that the product defect could lead to temporary or medically reversible adverse health consequences, with a low probability of serious harm. As a required action, Meriton Medical Devices, Inc. is actively removing the affected products from circulation. Detailed information concerning the specific models, specifications, and batch numbers of the recalled needles is provided in the accompanying "Medical Device Recall Event Report Form" attachment, guiding stakeholders through the recall process to ensure patient safety and compliance with regulatory standards.