China NMPA Product Recall - Support catheter

The National Medical Products Administration (NMPA) announced a Class III voluntary recall initiated by Covidien Medical Devices International Trading (Shanghai) Co., Ltd. on July 14, 2017. The recall pertains to specific support catheters (Registration No.: 国注进2号). The primary reason for this action was the discovery of an inaccurate expiration date printed on the product labels. Covidien Medical Devices International Trading (Shanghai) Co., Ltd. took responsibility for reporting this issue and implementing the recall. The regulatory framework for this action is overseen by the NMPA. Required actions involve the company voluntarily retrieving the affected support catheters from the market. Further detailed information regarding the models, specifications, and batch numbers of the products subject to this recall is available in the "Medical Device Recall Event Report Form" attachment, which provides comprehensive specifics for stakeholders. This ensures compliance with medical device safety standards and proper communication regarding product deficiencies.