China NMPA Product Recall - stoma chassis

ConvaTec Inc., in collaboration with ConvaTec (China) Medical Supplies Co., Ltd., initiated a voluntary Class III recall of specific ostomy bases. This action, reported to the National Medical Products Administration (NMPA) on November 2, 2017, and published on November 23, 2017, addresses critical labeling discrepancies. The primary issue involved printing errors on the packaging of ostomy bases (Registration Certificate No. 20162660708). A small portion of packaging boxes for batch number 7H02242 and model 411802 (Durahesive Molded Mouth Base) were erroneously labeled as model 411803 (Stomahesive Molded Mouth Base). Although the recall was declared, the specific affected batch (7H02242) was not imported into China, therefore posing no direct risk to the Chinese market. This voluntary recall aims to rectify the mislabeling and ensure product integrity and accurate information for users, demonstrating adherence to regulatory standards under the NMPA framework. Further details regarding corrective actions were provided in the Medical Device Recall Event Report Form.