# China NMPA Product Recall - Sterile scalp clip

Source: https://www.globalkeysolutions.net/records/china_product_recall/surgical-instruments-factory-shanghai-medical-instruments-group-co-ltd/3771e36f-b276-4942-b913-a6149c2ccd10/
Source feed: China

> China NMPA product recall for Sterile scalp clip by Surgical Instruments Factory, Shanghai Medical Instruments (Group) Co., Ltd. published December 22, 2020. Recall level: Level 3 Recall. Shanghai Medical Instruments (Group) Co., Ltd. Surgical Instruments Factory initiated a voluntary Cl

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shanghai Medical Instruments (Group) Co., Ltd. Surgical Instruments Factory voluntarily recalls sterile scalp clips.
- Company Name: Surgical Instruments Factory, Shanghai Medical Instruments (Group) Co., Ltd.
- Publication Date: 2020-12-22
- Product Name: Sterile scalp clip
- Recall Level: Level 3 Recall
- Recall Reason: The registration certificate number on the label is incorrect. It should be "沪械注准20202030199" but is actually printed as "沪械注准20202030119".
- Discovering Company: Surgical Instruments Factory, Shanghai Medical Instruments (Group) Co., Ltd.
- Manufacturing Company: Surgical Instruments Factory, Shanghai Medical Instruments (Group) Co., Ltd.
- Summary: Shanghai Medical Instruments (Group) Co., Ltd. Surgical Instruments Factory initiated a voluntary Class III recall of its sterile scalp clips, as announced by the National Medical Products Administration (NMPA) on December 22, 2020. The recall was prompted by an labeling error on product code N10115, model specification 14, from production batch number 200401. Specifically, the label incorrectly displayed the registration certificate number as “沪械注准20202030119” instead of the correct number, “沪械注准20202030199.” This discrepancy was identified by the company and reported to the Shanghai Municipal Drug Administration. The company's immediate action was to recall the affected sterile scalp clips to rectify the labeling inaccuracy. A Class III recall indicates that the product defect is unlikely to cause adverse health consequences. Detailed information on affected products is available in the accompanying Medical Device Recall Event Report Form.

Company: https://www.globalkeysolutions.net/companies/surgical-instruments-factory-shanghai-medical-instruments-group-co-ltd/bfd747d1-e622-4786-b132-c3a44a4c4e1e/
