China NMPA Product Recall - Disposable medical masks

Anhui Kaidun Protective Medical Supplies Co., Ltd. has initiated a voluntary Level III recall for specific batches of its disposable medical masks due to identified quality deficiencies. The company reported this recall on June 10, 2022, with the National Medical Products Administration (NMPA) publicly announcing it on June 13, 2022.The affected products are disposable medical masks, models 17.5cm x 9.5cm and 14.5cm x 9.5cm, associated with registration number

20202140165. The core issue is that masks from batch numbers 220106YA, 220315YA, 220410YA, YCRP2022042701, and 220530YA did not satisfy the company's internal factory inspection standards. This indicates a failure to meet established quality control benchmarks during the manufacturing process.Operating under the regulatory framework of the NMPA, Anhui Kaidun Protective Medical Supplies Co., Ltd. is taking proactive steps to remove these non-conforming products from the market. A Level III recall designation signifies that the use of or exposure to the product is not expected to cause serious adverse health consequences. The company's required action is to execute this recall to ensure product quality and consumer safety, with further details available in the "Medical Device Recall Event Report Form."