China NMPA Product Recall - Support catheter

Covidien Medical Devices International Trading (Shanghai) Co., Ltd., a subsidiary of Medtronic, initiated a voluntary Class III recall of specific support catheters (Registration No.: 国注进2号) in China and Singapore. This action, reported to the National Medical Products Administration (NMPA) on May 23, 2017, stemmed from an issue with inaccurate product expiration dates on labels. The recall document was published by the NMPA on July 18, 2017.The primary concern arose when Medtronic extended the shelf life of its TrailBlazer products from two to three years, effective October 6, 2016, following successful aging tests. However, a customer complaint on February 20, 2017, revealed that some product labels still displayed expiration dates based on the previous two-year shelf life. This discrepancy meant that the labels indicated a production date later than the actual date, despite the product remaining safe and effective for its extended three-year shelf life.Although the inaccurate labeling did not pose an additional safety risk to patients, Covidien opted for a recall to address the labeling error. The recall involved 2230 units produced or imported into China, with 2215 affected products already sold. The required action for Covidien Medical Devices International Trading (Shanghai) Co., Ltd. was to notify all affected customers and retrieve unused products from the market, ensuring compliance with regulatory standards for accurate product information.