China NMPA Product Recall - Sterile scalp clip

Shanghai Medical Instruments (Group) Co., Ltd. Surgical Instruments Factory initiated a voluntary Class III recall of its sterile scalp clips, as announced by the National Medical Products Administration (NMPA) on December 22, 2020. The recall was prompted by an labeling error on product code N10115, model specification 14, from production batch number 200401. Specifically, the label incorrectly displayed the registration certificate number as “沪械注准20202030119” instead of the correct number, “沪械注准20202030199.” This discrepancy was identified by the company and reported to the Shanghai Municipal Drug Administration. The company's immediate action was to recall the affected sterile scalp clips to rectify the labeling inaccuracy. A Class III recall indicates that the product defect is unlikely to cause adverse health consequences. Detailed information on affected products is available in the accompanying Medical Device Recall Event Report Form.