# China NMPA Product Recall - Single-use sampler

Source: https://www.globalkeysolutions.net/records/china_product_recall/shandong-kunao-medical-technology-co-ltd/ab9499a8-cb44-484b-81c7-f7f3caf12d24/
Source feed: China

> China NMPA product recall for Single-use sampler by Shandong Kun"ao Medical Technology Co., Ltd. published August 01, 2022. Recall level: Level 3 Recall. Shandong Kun'ao Medical Technology Co., Ltd. has initiated a voluntary Class III recall of its dispo

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shandong Kun'ao Medical Technology Co., Ltd. has voluntarily recalled its disposable samplers.
- Company Name: Shandong Kun"ao Medical Technology Co., Ltd.
- Publication Date: 2022-08-01
- Product Name: Single-use sampler
- Recall Level: Level 3 Recall
- Recall Reason: Inadequate product manufacturing protection
- Discovering Company: Shandong Kun'ao Medical Technology Co., Ltd.
- Manufacturing Company: Shandong Kun"ao Medical Technology Co., Ltd.
- Summary: Shandong Kun'ao Medical Technology Co., Ltd. has initiated a voluntary Class III recall of its disposable samplers, as reported to the National Medical Products Administration (NMPA) and the Shandong Provincial Drug Administration on August 1, 2022. The recall was prompted by inadequate product manufacturing protection, indicating a potential compromise in the quality or safety of the devices. Operating under China's comprehensive medical device regulatory framework, the company's action demonstrates a commitment to product compliance. While specific inspection dates were not detailed, the recall process (Recordation No.: Lu He Xie Bei 20220025) requires Shandong Kun'ao to systematically identify, retrieve, and manage all affected batches of its disposable samplers. This ensures that any potential risks to users are mitigated and that product quality standards are upheld. A Class III recall signifies that exposure to the affected product is not likely to cause adverse health consequences. Further specific details regarding affected product models, specifications, and batch numbers are documented in the associated "Medical Device Recall Form".

Company: https://www.globalkeysolutions.net/companies/shandong-kunao-medical-technology-co-ltd/7900d2e9-1615-452e-a0ed-c110645d3372/