China NMPA Product Recall - Oxylog 3000 plus ventilator

Dräger Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Level III recall for its Oxylog 3000 plus ventilators, a measure announced by the National Medical Products Administration (NMPA) on December 24, 2020. The recall was prompted by an inconsistency in regulatory information: while the registration certificate number on the ventilator's physical label was correctly updated following an approval, the corresponding instruction manual (version 5705324-15) did not reflect this change simultaneously. This discrepancy resulted in differing registration certificate numbers between the product's label and its user documentation, potentially causing confusion regarding the device's official status. Under the regulatory guidance of the NMPA, Dräger Medical Devices (Shanghai) Co., Ltd. proactively reported this issue and is undertaking corrective action. The company is recalling all affected ventilators, specifically those under Registration Certificate No.: 国械注进20153084157, to ensure full compliance with national medical device regulations and rectify the documentation error. Further details concerning the specific product models, specifications, and batches involved in this recall are available in the "Medical Device Recall Event Report Form," which accompanied the NMPA's public notification. This event underscores the critical importance of maintaining meticulous accuracy and consistency across all product information components, including both external labeling and internal user manuals, to uphold regulatory standards and ensure clarity for users.