# China NMPA Product Recall - Disposable nasal oxygen cannula

Source: https://www.globalkeysolutions.net/records/china_product_recall/shijiazhuang-xidebao-medical-equipment-co-ltd/c22c5938-2c36-4dc1-ba78-993b3e8ee231/
Source feed: China

> China NMPA product recall for Disposable nasal oxygen cannula by Shijiazhuang Xidebao Medical Equipment Co., Ltd. published August 25, 2020. Recall level: Level 3 Recall. Shijiazhuang Xidebao Medical Device Co., Ltd. has initiated a voluntary Level III recall for its Dis

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shijiazhuang Xidebao Medical Device Co., Ltd. voluntarily recalls disposable nasal oxygen cannulas.
- Company Name: Shijiazhuang Xidebao Medical Equipment Co., Ltd.
- Publication Date: 2020-08-25
- Product Name: Disposable nasal oxygen cannula
- Recall Level: Level 3 Recall
- Recall Reason: The National Medical Device Sampling Inspection Report No. AH2020-QGC-00045 dated August 20, 2020, indicated that the sterility test result did not meet the requirements.
- Discovering Company: Shijiazhuang Xidebao Medical Equipment Co., Ltd.
- Manufacturing Company: Shijiazhuang Xidebao Medical Equipment Co., Ltd.
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/shijiazhuang-xidebao-medical-equipment-co-ltd/46ee514e-9b09-4844-93f3-361fdc31e001/