China NMPA Product Recall - Disposable medical masks

Shaoyang Zhikang Medical Device Co., Ltd. has initiated a Class III voluntary recall of its Disposable Medical Masks, as announced by the National Medical Products Administration (NMPA) on August 6, 2019. The recall stems from a critical quality issue where the breaking strength at the connection point between the mask strap and the mask body failed to meet specified requirements. The affected products include Disposable Medical Masks with Registration No. "湘械注准20172640243", specifically batch number 20190302. A total of 12,500 packs of Type A, ear loop, medium-sized masks are involved in this recall, impacting sales in Shaoyang City, Hunan Province. Under the guidance of the NMPA, Shaoyang Zhikang Medical Device Co., Ltd. has established a product recall leadership team. Their sales department is tasked with notifying distributors through various communication channels. Recalled products are to be segregated in a dedicated warehouse. Following quality evaluation, products deemed substandard will be destroyed under the supervision of the drug regulatory authority. Conversely, any products assessed as meeting quality standards may be returned to the market only with explicit approval from the regulatory body. This recall ensures compliance with medical device safety standards set forth by the NMPA.