# China NMPA Product Recall - Medical laser fiber

Source: https://www.globalkeysolutions.net/records/china_product_recall/shanghai-leifukang-medical-equipment-co-ltd/0c8f07a3-889e-4b9d-aa06-e7c4301e32c7/
Source feed: China

> China NMPA product recall for Medical laser fiber by Shanghai Leifukang Medical Equipment Co., Ltd. published December 03, 2021. Recall level: Level 3 Recall. On December 3, 2021, Shanghai Leifukang Medical Equipment Co., Ltd. initiated a voluntary Class III 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shanghai Leifukang Medical Equipment Co., Ltd. is voluntarily recalling its medical laser fiber optic equipment.
- Company Name: Shanghai Leifukang Medical Equipment Co., Ltd.
- Publication Date: 2021-12-03
- Product Name: Medical laser fiber
- Recall Level: Level 3 Recall
- Recall Reason: The instructions accompanying the product are inconsistent with the user manual (instructions) filed by the company with the Shanghai Municipal Drug Administration.
- Discovering Company: Shanghai Leifukang Medical Equipment Co., Ltd.
- Manufacturing Company: Shanghai Leifukang Medical Equipment Co., Ltd.
- Summary: On December 3, 2021, Shanghai Leifukang Medical Equipment Co., Ltd. initiated a voluntary Class III recall of its medical laser fiber optic devices. This action was taken due to significant inconsistencies identified between the product's accompanying instructions and the user manual officially filed with the Shanghai Municipal Drug Administration. The National Medical Products Administration (NMPA) oversees such regulatory actions to ensure medical device compliance and patient safety. The specific medical laser fiber optic devices affected by this recall are identifiable by Registration Certificate No.: 沪械注准20202010317. The voluntary recall signifies the company's proactive measure to address the identified discrepancy, which, while not immediately life-threatening, could potentially lead to user confusion or incorrect application of the device. Further details regarding specific models, specifications, and batch numbers are documented in the "Medical Device Recall Event Report Form." This incident underscores the critical importance of maintaining accurate and consistent documentation for medical devices, aligning all user-facing materials with approved regulatory filings to prevent potential misuse and uphold public health standards.

Company: https://www.globalkeysolutions.net/companies/shanghai-leifukang-medical-equipment-co-ltd/6b6ea0e7-90a5-4804-a01c-57cfdccb6603/