# China NMPA Product Recall - Disposable puncture device

Source: https://www.globalkeysolutions.net/records/china_product_recall/jiangsu-celtech-medical-technology-co-ltd/8f798f08-c9f8-4e41-a8e1-1c6cf1512564/
Source feed: China

> China NMPA product recall for Disposable puncture device by Jiangsu Celtech Medical Technology Co., Ltd. published November 29, 2018. Recall level: Level 3 Recall. Jiangsu Celte Medical Technology Co., Ltd. has initiated a voluntary Class III recall of its disposa

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Jiangsu Celtech Medical Technology Co., Ltd. has initiated a voluntary recall of disposable puncture instruments.
- Company Name: Jiangsu Celtech Medical Technology Co., Ltd.
- Publication Date: 2018-11-29
- Product Name: Disposable puncture device
- Recall Level: Level 3 Recall
- Recall Reason: In the 2018 national medical device spot check, it failed to meet the standard requirements for "fitting performance, sealing and gas barrier".
- Discovering Company: Jiangsu Celtech Medical Technology Co., Ltd.
- Manufacturing Company: Jiangsu Celtech Medical Technology Co., Ltd.
- Summary: Jiangsu Celte Medical Technology Co., Ltd. has initiated a voluntary Class III recall of its disposable puncture devices (Registration Certificate Code: Su Xie Zhu Zhun 20172222199). This action follows findings from the 2018 national medical device spot check, which identified non-compliance with established standards for the product's "fitting performance, sealing, and gas barrier properties." The recall was officially reported to the National Medical Products Administration (NMPA) and the relevant Provincial Food and Drug Administration Department on November 28, 2018, with public notification on November 29, 2018. The affected devices, specifically model 18052803, were produced in a batch size of 100 sets for distribution in China. As a required action, the company is recalling all units of the non-compliant product. According to the recall report, no stock of the affected batch remains unsold, indicating a complete recall effort. The company is responsible for ensuring all distributors are promptly informed and for the proper handling of the recalled medical devices to mitigate any potential risks associated with the identified performance issues. This measure underscores the company's commitment to regulatory compliance and patient safety under the NMPA's oversight.

Company: https://www.globalkeysolutions.net/companies/jiangsu-celtech-medical-technology-co-ltd/740c44e7-f51e-485a-86ce-b564a2bf145b/