China NMPA Product Recall - 2ml of surgical sealant

Baxter Medical Products Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its 2ml surgical sealant (Registration Certificate No.: 国械注进20193022073) on May 28, 2021. This action was prompted by a critical packaging discrepancy affecting product integrity and user information. The primary issue involved an incorrect English sticker label inside the product box, which mistakenly indicated a product specification of 8ml, contrasting with the actual 2ml volume. Conversely, the Chinese sticker label affixed to the exterior of the box accurately displayed the 2ml specification. This labeling error posed a risk of confusion regarding the actual product volume, potentially impacting proper medical use. The recall, indexed as JGXX-2021-10262 and published by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration, underscores the company’s commitment to product safety and compliance with regulatory standards. The company has taken the required action of recalling affected batches to rectify the discrepancy and ensure all product information is accurate and consistent across all packaging elements. Further details on specific models, specifications, and batch numbers are available in the "Medical Device Recall Event Report Form" associated with this announcement.