# China NMPA Product Recall - Infant incubator

Source: https://www.globalkeysolutions.net/records/china_product_recall/nanjing-jinling-automatic-temperature-control-bed-co-ltd/bfc62089-c4cf-436c-a3f1-6904af7a5411
Source feed: China

> China NMPA product recall for Infant incubator by Nanjing Jinling Automatic Temperature Control Bed Co., Ltd. published March 26, 2020. Recall level: Level 3 Recall. Nanjing Jinling Automatic Temperature Control Bed Co., Ltd. initiated a voluntary Class III recall f

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Nanjing Jinling Automatic Temperature Control Bed Co., Ltd. voluntarily recalls infant incubators.
- Company Name: Nanjing Jinling Automatic Temperature Control Bed Co., Ltd.
- Publication Date: 2020-03-26
- Product Name: Infant incubator
- Recall Level: Level 3 Recall
- Recall Reason: In the 2019 national medical device spot check, it failed to meet the product registration standards.
- Discovering Company: Nanjing Jinling Automatic Temperature Control Bed Co., Ltd.
- Manufacturing Company: Nanjing Jinling Automatic Temperature Control Bed Co., Ltd.
- Summary: Nanjing Jinling Automatic Temperature Control Bed Co., Ltd. initiated a voluntary Class III recall for its infant incubators, announced on March 26, 2020. This action followed a 2019 national medical device spot check, which revealed that the company's infant incubators failed to meet product registration standards, indicating non-compliance with established regulatory requirements. The affected product carries the National Medical Device Registration Certificate 20183081875.

The regulatory framework overseeing this recall includes the National Medical Products Administration (NMPA) and the Jiangsu Provincial Drug Administration, which published the recall notice. A Class III recall signifies that the use of or exposure to the non-compliant product is not expected to cause adverse health consequences.

As a direct consequence of this non-compliance, Nanjing Jinling Automatic Temperature Control Bed Co., Ltd. is required to remove the identified infant incubators from the market. Comprehensive details regarding the specific models, specifications, and batch numbers of the products subject to this recall are provided in a "Medical Device Recall Event Report Form," which is the official document for stakeholders to reference for full information. This recall emphasizes the ongoing efforts to ensure medical device safety and adherence to national standards.

Company: https://www.globalkeysolutions.net/companies/nanjing-jinling-automatic-temperature-control-bed-co-ltd/c422ceec-8d95-49b6-bc65-cd7072a5f69f