China NMPA Product Recall - Breathing circuit; disposable heat exchanger/filter; disposable heat exchanger; filter; closed suction device; oropharyngeal airway; closed suction device

Covidien Medical Devices International Trading (Shanghai) Co., Ltd. initiated a voluntary Class II recall on June 22, 2021, affecting several medical devices, including breathing circuits, disposable heat exchangers/filters, filters, closed suction devices, and oropharyngeal airways. This action was prompted by a report from their former supplier, Stellil Milano, concerning temperature and humidity deviations at its ethylene oxide sterilization facility. While an internal assessment determined these deviations did not compromise the sterility or functionality of most products, a critical issue arose with a specific production batch. For this batch, essential sterilization process data was missing, making it impossible to confirm its sterility. Despite the absence of global complaints or adverse events related to this specific problem, Covidien chose to conduct the recall as a precautionary measure. The recall process is overseen within the regulatory framework of the National Medical Products Administration (NMPA) in China. Detailed information regarding the models, specifications, and affected batches is documented in the accompanying Medical Device Recall Event Report Form.