# China NMPA Product Recall - scalpel handle

Source: https://www.globalkeysolutions.net/records/china_product_recall/shanghai-kangqiao-dental-medical-equipment-factory/83170cf0-f942-4193-9fed-029c64914972/
Source feed: China

> China NMPA product recall for scalpel handle by Shanghai Kangqiao Dental Medical Equipment Factory published December 10, 2020. Recall level: Level 3 Recall. On December 10, 2020, Shanghai Kangqiao Dental Medical Device Factory initiated a voluntary Class II

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shanghai Kangqiao Dental Medical Equipment Factory voluntarily recalls surgical scalpel handles.
- Company Name: Shanghai Kangqiao Dental Medical Equipment Factory
- Publication Date: 2020-12-10
- Product Name: scalpel handle
- Recall Level: Level 3 Recall
- Recall Reason: The issues involve products that, due to quality supervision spot checks, were found to "not meet mandatory standards or the technical requirements for registered or filed products."
- Discovering Company: Shanghai Kangqiao Dental Medical Equipment Factory
- Manufacturing Company: Shanghai Kangqiao Dental Medical Equipment Factory
- Summary: On December 10, 2020, Shanghai Kangqiao Dental Medical Device Factory initiated a voluntary Class III recall of its surgical scalpel handles. This action followed a quality supervision spot check, which identified critical non-compliance issues. Specifically, the product failed to meet either mandatory national standards or the technical specifications outlined in its registered or filed documentation. This deficiency raised concerns about the product's quality and potential performance. The regulatory oversight for this recall is provided by the National Medical Products Administration (NMPA), with direct involvement from the Shanghai Municipal Drug Administration, ensuring appropriate measures are taken to protect public health. The affected surgical scalpel handles are identified by Registration Certificate No.: 沪浦械备20150128号. As a required action, Shanghai Kangqiao Dental Medical Device Factory must remove all non-conforming units from the market. Further detailed information regarding specific models, specifications, and batch numbers is available in the Medical Device Recall Event Report Form.

Company: https://www.globalkeysolutions.net/companies/shanghai-kangqiao-dental-medical-equipment-factory/6005488a-ab21-4a92-a8fa-fca27ff7055f/