China NMPA Product Recall - Ventilator

Covidien Medical Devices International Trading (Shanghai) Co., Ltd. initiated a Level II voluntary recall of its manufactured ventilators, as announced on June 20, 2019. This action was taken due to product issues where the visual and auditory alarms failed to meet applicable standards. The affected ventilators are identified by Registration Certificate Nos. 20153543380 and 20143545696. This recall was managed under the oversight of the Shanghai Food and Drug Administration, referencing recall event 2019-144, and falls within the regulatory framework of the National Medical Products Administration (NMPA). The company is responsible for addressing the identified deficiencies to ensure product compliance and patient safety. Further details regarding specific models, specifications, and batches are available in the attached Medical Device Recall Event Report Form.