# China NMPA Product Recall - Soft hydrophilic contact mirror

Source: https://www.globalkeysolutions.net/records/china_product_recall/realtek-shanghai-trading-co-ltd/8bf6117e-384c-4206-b754-195bb6d1b060/
Source feed: China

> China NMPA product recall for Soft hydrophilic contact mirror by Realtek (Shanghai) Trading Co., Ltd. published July 26, 2019. Recall level: Level 3 Recall. On July 26, 2019, Shitong (Shanghai) Trading Co., Ltd. initiated a voluntary Class III recall of its

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Realtek (Shanghai) Trading Co., Ltd. is voluntarily recalling soft hydrophilic contact lenses.
- Company Name: Realtek (Shanghai) Trading Co., Ltd.
- Publication Date: 2019-07-26
- Product Name: Soft hydrophilic contact mirror
- Recall Level: Level 3 Recall
- Recall Reason: The product's overall diameter does not meet the product registration standards.
- Discovering Company: Realtek (Shanghai) Trading Co., Ltd.
- Manufacturing Company: Realtek (Shanghai) Trading Co., Ltd.
- Summary: On July 26, 2019, Shitong (Shanghai) Trading Co., Ltd. initiated a voluntary Class III recall of its soft hydrophilic contact lenses. This action stemmed from a 2019 national random inspection, which revealed that the total diameter of some manufactured products did not meet the established product registration standards. The affected contact lenses are identified under Registration Certificate No. 国械注进20173226534. This recall is overseen by the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration, aligning with China's robust regulatory framework for medical devices. A Class III recall indicates that the product defect, while a deviation, is unlikely to cause significant adverse health consequences. Shitong (Shanghai) Trading Co., Ltd. is responsible for implementing this recall to address the non-compliance. Further specific details regarding the models, specifications, and batch numbers of the impacted products are contained within the "Medical Device Recall Event Report Form," serving as the official documentation for this event. This voluntary market action demonstrates the company's commitment to correcting product quality deviations identified through regulatory surveillance, ensuring adherence to medical device standards and product integrity.

Company: https://www.globalkeysolutions.net/companies/realtek-shanghai-trading-co-ltd/28d74b2b-134d-460d-8547-243d8f4a4b46/