China NMPA Product Recall - Disposable intravenous infusion needles

Yunnan Haodi Medical Device Co., Ltd. initiated a voluntary Class III recall of its disposable intravenous infusion needles (Registration No.: 20163150682), as reported on October 19, 2021. The primary issue identified was a critical labeling inconsistency on the product's seal, where the production year and expiration year were printed identically. This error posed a potential risk for confusion regarding the product's actual shelf life and safety for patients. The National Medical Products Administration (NMPA) oversees such regulatory actions in China, ensuring compliance with medical device safety standards. While the document does not specify a particular inspection date, the company proactively self-identified this labeling discrepancy and commenced the recall to address the potential risk. The required action involves the removal of affected disposable intravenous infusion needles from circulation, with specific models, specifications, and batches detailed in the accompanying "Medical Device Report Form." A Class III recall indicates that the use of, or exposure to, the product is not likely to cause adverse health consequences.