China NMPA Product Recall - High-pressure contrast injection extension tube

Merit Medical Systems, Inc., via its affiliate Merit Medical Devices (Beijing) Co., Ltd., announced a voluntary Class III recall of its high-pressure contrast injection extension tubes. This recall, publicized on October 30, 2018, was initiated due to a labeling error found on the product, identified by Registration Certificate No.: 20163770745. The action falls under the regulatory purview of the National Medical Products Administration (NMPA) in China, which hosted the official recall notification. While the document does not specify inspection dates, the recall itself represents a critical corrective measure addressing the identified non-compliance. The core issue centers on inaccurate product labeling, which could potentially impact product safety or appropriate usage instructions. As a required action, Merit Medical Systems, Inc. has voluntarily withdrawn the affected devices from the market to mitigate any potential risks associated with the mislabeling. Comprehensive details regarding the specific affected product models, specifications, and batch numbers are documented within the 'Medical Device Recall Event Report Form,' cited as an attachment to the formal recall notice. This proactive step underscores the company's commitment to regulatory adherence and patient safety, resolving the defect through a structured recall process overseen by the medical device regulatory authority.