China NMPA Product Recall - Respiratory mask and tubing system

Suzhou Kaiditai Medical Technology Co., Ltd. has initiated a voluntary Level III recall for its Respiratory Masks and Tubing Accessories System. This action, reported on December 10, 2021, and published by the National Medical Products Administration (NMPA) on December 15, 2021, addresses a significant labeling discrepancy. The core issue involves incorrect production dates printed on the labels of the affected masks. Specifically, 500 units of the product, identified by batch number 210907B071, sold within China, were found to have this manufacturing error. The recall is managed under the regulatory framework of the NMPA and the Jiangsu Provincial Food and Drug Administration. As part of the required corrective actions, Suzhou Kaiditai Medical Technology Co., Ltd. is notifying distributors of the recall and instructing them to return all affected unopened packaging with the erroneous labels. Additionally, the company mandates the destruction of all replaced packaging bags, including their labels, to prevent any further distribution or confusion stemming from the incorrect dates, thereby upholding product integrity and regulatory compliance.