China NMPA Product Recall - Support catheter

This National Medical Products Administration (NMPA) document details a Class III voluntary recall initiated by Covidien Medical Devices International Trading (Shanghai) Co., Ltd. The recall, reported on May 23, 2017, and published July 19, 2017, concerns "Support Catheters" (Registration No.: CICPHIC 20163770366), manufactured by ev3, Inc.

The core issue stems from an inaccurate expiration date on product labels. The manufacturer, Medtronic, had extended the shelf life of these catheters from two to three years, effective October 6, 2016, based on updated aging tests. However, some product labels continued to display the original two-year expiration period. This discrepancy meant that the manufacturing date calculated from the label's expiration date appeared later than the actual production date for affected batches.

Upon receiving a customer complaint on February 20, 2017, Medtronic determined that while the mislabeling presented no additional risk to patient safety, a recall was necessary to address the regulatory non-conformity. The recall affects 2230 units across various models and specifications within China and Singapore. Covidien Medical Devices International Trading (Shanghai) Co., Ltd. is responsible for notifying affected customers to retrieve all unused products. This action ensures compliance with NMPA regulations regarding accurate product information.