# China NMPA Product Recall - Electronic thermometer

Source: https://www.globalkeysolutions.net/records/china_product_recall/beijing-luyuan-hengtai-medical-equipment-co-ltd/978d8ffb-5e75-4353-bc2a-58a340b8a87a/
Source feed: China

> China NMPA product recall for Electronic thermometer by Beijing Luyuan Hengtai Medical Equipment Co., Ltd. published October 08, 2019. Recall level: Level 3. Beijing Luyuan Hengtai Medical Device Co., Ltd. initiated a voluntary Level III recall for its elect

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beijing Luyuan Hengtai Medical Device Co., Ltd. voluntarily recalls electronic thermometers.
- Company Name: Beijing Luyuan Hengtai Medical Equipment Co., Ltd.
- Publication Date: 2019-10-08
- Product Name: Electronic thermometer
- Recall Level: Level 3
- Recall Reason: The inspection results for item 6.1, where the external markings of the equipment or equipment components do not meet the standard requirements, indicate that the error is only due to incorrect labeling information and does not involve product safety or effectiveness, or compliance with regulatory requirements.
- Discovering Company: Beijing Luyuan Hengtai Medical Equipment Co., Ltd.
- Manufacturing Company: Beijing Luyuan Hengtai Medical Equipment Co., Ltd.
- Summary: Beijing Luyuan Hengtai Medical Device Co., Ltd. initiated a voluntary Level III recall for its electronic thermometers, specifically model LY-302C, batch number 1810030. This action, reported on September 24, 2019, and publicized by the National Medical Products Administration (NMPA) on October 8, 2019, addresses a non-compliance issue concerning product labeling. The core violation involves an error in item 6.1, "External Markings of Equipment or Equipment Components," which is solely a labeling deficiency and does not impact the product's safety or effectiveness. To meet regulatory requirements, the company outlined several corrective actions. These include issuing warning notices to distributors for the return of affected products. Internally, the company will rectify the products by adding the required clause 6.11 to their labeling. Furthermore, an internal assessment meeting will be held, and relevant personnel will receive training. Finally, all returned products will have their labels replaced with compliant information and undergo re-inspection before being resent to the market.

Company: https://www.globalkeysolutions.net/companies/beijing-luyuan-hengtai-medical-equipment-co-ltd/764410fb-6409-4238-b75d-090df08ef174/