China NMPA Product Recall - stoma chassis

ConvaTec Inc., a medical device manufacturer, initiated a voluntary Class III recall of specific ostomy bases, managed through its Chinese agent, ConvaTec (China) Medical Supplies Co., Ltd. This action was officially reported by the National Medical Products Administration (NMPA) on November 23, 2017. The primary reason for the recall is a printing error found on the labeling of certain product packaging. Specifically, commercially available boxes of ostomy bases, identified by batch number 7H02242 and model 411802 (Durahesive Molded Mouth Base), were incorrectly labeled as model 411803 (Stomahesive Molded Mouth Base). This mislabeling could lead to confusion regarding the precise product type, which is critical for medical devices designed for ostomy excrement treatment. While the document indicates that the particular erroneous batch (7H02242) was not imported into China, the recall was proactively reported by the Chinese subsidiary, adhering to regulatory expectations for products distributed under National Medical Device Registration Certificate 20162660708. The required action involves the manufacturer undertaking corrective measures to address this labeling inaccuracy and ensure proper product identification for patient safety and efficacy, highlighting the NMPA's strict oversight on medical product information.