China NMPA Product Recall - stoma chassis

ConvaTec Inc., in conjunction with its agent ConvaTec (China) Medical Supplies Co., Ltd., initiated a Class III voluntary recall of certain ostomy bases due to a significant labeling error. This recall, reported to the National Medical Products Administration (NMPA) on November 23, 2017, concerned products under National Medical Device Registration Certificate No. 20162660708. The main issue involved a printing mistake on a small quantity of packaging boxes for batch number 7H02242 and model 411802 (Durahesive Molded Mouth Base), which were incorrectly marked as model 411803 (Stomahesive Molded Mouth Base). This mislabeling posed a risk of product confusion. Although the specific affected batch was not imported into China, ConvaTec undertook the recall to ensure product accuracy and compliance with regulatory standards. The required action involves the systematic removal of these mislabeled products from commercial availability, emphasizing the critical need for precise product identification in medical device packaging.