China NMPA Product Recall - Disposable sterile syringe with needle

Yunnan Haodi Medical Device Co., Ltd. has initiated a voluntary Class III recall for its disposable sterile syringes with needles, officially published on October 19, 2021. This decisive action stems from the discovery of inaccurate and untrue product labels and markings on the devices, a critical issue impacting product identification and information integrity. The affected products are identified under Registration No.: 20163151123. The company itself reported these significant discrepancies to the authorities on October 14, 2021, leading to this recall.

Operating under the regulatory framework of the National Medical Products Administration (NMPA), Yunnan Haodi is committed to addressing these violations. A Class III recall is designated for situations where the use of, or exposure to, a violative product is not likely to cause adverse health consequences. Despite this classification, the recall ensures that products with misleading information are removed from circulation to uphold quality standards and maintain public trust. Comprehensive details concerning the specific models, specifications, and batches impacted are documented in an accompanying "Medical Device Recall Event Report Form," ensuring transparency and accountability in the resolution process. This measure reinforces the importance of accurate product information in the medical device industry.