# China NMPA Product Recall - Hot compress

Source: https://www.globalkeysolutions.net/records/china_product_recall/anhui-kangtai-medical-equipment-co-ltd/681034ac-a339-4c40-a155-3f50f4b8db3a/
Source feed: China

> China NMPA product recall for Hot compress by Anhui Kangtai Medical Equipment Co., Ltd. published August 10, 2022. Recall level: Level 3 Recall. Anhui Jintai Medical Device Co., Ltd. initiated a voluntary Class III recall of its heating patches 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Anhui Jintai Medical Equipment Co., Ltd. voluntarily recalls its heat therapy patches.
- Company Name: Anhui Kangtai Medical Equipment Co., Ltd.
- Publication Date: 2022-08-10
- Product Name: Hot compress
- Recall Level: Level 3 Recall
- Recall Reason: The heat therapy patch with batch number 20211115 failed the random inspection.
- Discovering Company: Anhui Jintai Medical Equipment Co., Ltd.
- Manufacturing Company: Anhui Kangtai Medical Equipment Co., Ltd.
- Summary: Anhui Jintai Medical Device Co., Ltd. initiated a voluntary Class III recall of its heating patches following a failed random inspection. The recall, publicized by the National Medical Products Administration (NMPA) and the Anhui Provincial Drug Administration on August 10, 2022, specifically targets heating patches identified with batch number 20211115. This action was taken after the company's internal report confirmed that products from this particular batch did not meet established quality or safety standards during routine random testing.
The regulatory framework overseeing this recall includes both the national-level NMPA and the provincial Anhui Drug Administration, which are responsible for ensuring the safety and efficacy of medical devices within China. The Class III designation for this recall indicates that the use of or exposure to the recalled product is not likely to cause adverse health consequences, yet it still warrants corrective action to address the non-compliance.
As a required action, Anhui Jintai Medical Device Co., Ltd. is undertaking the full retrieval of all affected heating patches from the market. Further details regarding specific product models, specifications, and the full scope of the affected batches are documented in an accompanying 'Medical Device Recall Event Report Form,' though the precise nature of the failure in the random inspection was not elaborated in the public announcement. This proactive measure by Anhui Jintai demonstrates compliance with regulatory expectations to ensure product quality.

Company: https://www.globalkeysolutions.net/companies/anhui-kangtai-medical-equipment-co-ltd/bdb38ade-0877-42d4-a062-563ae6249d44/