China NMPA Product Recall - Transdermal monitoring device

On December 19, 2019, Radeomet Medical Equipment (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its Transcutaneous Monitoring Device (Registration Certificate No.: 国械注进20172210094). This action was taken in response to the discovery of an auxiliary Chinese label incorrectly describing the product model affixed to the outer packaging. The National Medical Products Administration (NMPA), specifically via the Shanghai Municipal Drug Administration Website, published this recall notice. It is important to note that while the labeling issue constitutes a non-conformance, the core performance and safety of the Transcutaneous Monitoring Device remain unaffected by this packaging discrepancy. The company has provided a "Medical Device Recall Event Report Form" detailing specific models, specifications, and batches involved, requiring distributors and healthcare providers to take appropriate actions to address the mislabeled products according to the regulatory framework. The recall aims to ensure accurate product information is presented to consumers and healthcare professionals.