China NMPA Product Recall - Disposable nasal oxygen cannula

Shijiazhuang Xidebao Medical Device Co., Ltd. has initiated a voluntary Level III recall for its Disposable Nasal Oxygen Tubes (Model YB-A type, batch number 191201). The recall stems from the product's failure to meet sterility requirements, specifically a bacterial test, during the 2020 National Medical Device Supervision and Inspection. The issue was confirmed by a sampling inspection report dated August 20, 2020. A total of 5357 units were produced, with 5250 units sold within China being affected. This action falls under the regulatory framework of the National Medical Products Administration (NMPA) and the Hebei Provincial Drug Administration.

In response, the company is taking several required actions. These include contacting distributors to retrieve all substandard products from the market. Furthermore, Shijiazhuang Xidebao is conducting a thorough self-inspection of its quality management system, re-inspecting retained product samples, and intends to formally appeal the testing methods used by the regulatory authority. This comprehensive approach aims to ensure product safety and compliance with medical device standards.