China NMPA Product Recall - medical masks

Hebi Liyangli Medical Device Co., Ltd. initiated a voluntary Level III recall of 120,000 units of medical masks (batch number 20200122) on March 29, 2020, with the National Medical Products Administration (NMPA) publishing the notice on April 6, 2020. This action followed provincial bureau inspections and spot checks that identified non-compliance in the mask straps and contamination in some products. The company confirmed these quality issues through internal investigations and sample testing, determining that the products did not meet required standards. In response, Hebi Liyangli Medical Device Co., Ltd. promptly developed and implemented a comprehensive recall plan. They notified all purchasing units about the non-compliant products and instructed the return of all affected medical masks. The recalled products were subsequently segregated: those meeting quality specifications were repackaged according to internal inspection rules, while all non-compliant units were safely disposed of through incineration. This proactive measure ensures the removal of substandard medical devices from circulation, adhering to the regulatory framework set by the NMPA for medical device safety.