# China NMPA Product Recall - Infant incubator

Source: https://www.globalkeysolutions.net/records/china_product_recall/likang-huayao-biotechnology-shanghai-co-ltd/18151cce-4675-45f0-9445-f6fd343d3aaa/
Source feed: China

> China NMPA product recall for Infant incubator by Likang Huayao Biotechnology (Shanghai) Co., Ltd. published December 22, 2020. Recall level: Level 3 Recall. Likang Huayao Biotechnology (Shanghai) Co., Ltd. has initiated a voluntary Class III recall for its 

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Likang Huayao Biotechnology (Shanghai) Co., Ltd. has voluntarily recalled its infant incubators.
- Company Name: Likang Huayao Biotechnology (Shanghai) Co., Ltd.
- Publication Date: 2020-12-22
- Product Name: Infant incubator
- Recall Level: Level 3 Recall
- Recall Reason: The description of the skin temperature control range in the finished product inspection procedure is inconsistent with the product technical requirements.
- Discovering Company: Likang Huayao Biotechnology (Shanghai) Co., Ltd.
- Manufacturing Company: Likang Huayao Biotechnology (Shanghai) Co., Ltd.
- Summary: Likang Huayao Biotechnology (Shanghai) Co., Ltd. has initiated a voluntary Class III recall for its infant incubators, as reported by the National Medical Products Administration (NMPA) on December 22, 2020. This action follows on-site inspections conducted by the Shanghai Municipal Drug Administration on December 8-9, 2020. The inspections revealed a significant non-conformity where the description of the skin temperature control range in the finished product inspection procedure was inconsistent with the product's official technical requirements. The affected infant incubators are registered under Certificate No. 国械注准20153080700. The company is required to recall the identified products to rectify this discrepancy, ensuring adherence to established safety and performance standards for medical devices. Specific details regarding the models, specifications, and batch numbers of the impacted devices are available in the accompanying "Medical Device Recall Event Report Form." This recall underscores the importance of strict quality control and regulatory compliance in the manufacturing of critical medical equipment.

Company: https://www.globalkeysolutions.net/companies/likang-huayao-biotechnology-shanghai-co-ltd/a9367c94-dcc5-49c7-b7fe-02c2c05c8569/