# China NMPA Product Recall - Transdermal monitoring device

Source: https://www.globalkeysolutions.net/records/china_product_recall/radiometer-medical-equipment-shanghai-co-ltd/7bee90bb-0a46-42e1-83af-da403c3764dc/
Source feed: China

> China NMPA product recall for Transdermal monitoring device by Radiometer Medical Equipment (Shanghai) Co., Ltd. published December 19, 2019. Recall level: Level 3 Recall. On December 19, 2019, Radeomet Medical Equipment (Shanghai) Co., Ltd. initiated a voluntary Class II

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Radomet Medical Equipment (Shanghai) Co., Ltd. has initiated a voluntary recall of its transcutaneous ...
- Company Name: Radiometer Medical Equipment (Shanghai) Co., Ltd.
- Publication Date: 2019-12-19
- Product Name: Transdermal monitoring device
- Recall Level: Level 3 Recall
- Recall Reason: The product's outer box had an extra Chinese label with an incorrect model description.
- Discovering Company: Radiometer Medical Equipment (Shanghai) Co., Ltd.
- Manufacturing Company: Radiometer Medical Equipment (Shanghai) Co., Ltd.
- Summary: On December 19, 2019, Radeomet Medical Equipment (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its Transcutaneous Monitoring Device (Registration Certificate No.: 国械注进20172210094). This action was taken in response to the discovery of an auxiliary Chinese label incorrectly describing the product model affixed to the outer packaging. The National Medical Products Administration (NMPA), specifically via the Shanghai Municipal Drug Administration Website, published this recall notice. It is important to note that while the labeling issue constitutes a non-conformance, the core performance and safety of the Transcutaneous Monitoring Device remain unaffected by this packaging discrepancy. The company has provided a "Medical Device Recall Event Report Form" detailing specific models, specifications, and batches involved, requiring distributors and healthcare providers to take appropriate actions to address the mislabeled products according to the regulatory framework. The recall aims to ensure accurate product information is presented to consumers and healthcare professionals.

Company: https://www.globalkeysolutions.net/companies/radiometer-medical-equipment-shanghai-co-ltd/f92b69f4-700c-4f10-b265-b088de493537/