China NMPA Product Recall - Puritan Bennett 840 ventilator

Covidien Medical Devices International Trading (Shanghai) Co., Ltd., the Chinese responsible unit for manufacturer Covidien LLC, initiated a voluntary recall of 5819 Puritan Bennett 840 ventilators in China. The recall was reported on February 9, 2015, and publicly announced by the National Medical Products Administration (NMPA) on March 10, 2015. This proactive field corrective action specifically addresses the absence of appropriate Chinese language labeling for the affected ventilators, which include various serial numbers. The recall document explicitly states that this measure is unrelated to any quality or safety issues with the Puritan Bennett 840 ventilator itself, highlighting a regulatory compliance matter. Overseen by the NMPA, this action falls under the framework governing medical device registration and distribution in China. The required action involves Covidien deploying personnel to provide and affix Chinese labels directly to the Puritan Bennett 840 ventilators already distributed to customers, ensuring adherence to local regulatory standards.