# China NMPA Product Recall - Vacuum blood collection tubes

Source: https://www.globalkeysolutions.net/records/china_product_recall/chongqing-xinwen-medical-equipment-co-ltd/3999d58a-9701-46f3-91f7-cd2cf38282b5/
Source feed: China

> China NMPA product recall for Vacuum blood collection tubes by Chongqing Xinwen Medical Equipment Co., Ltd. published October 30, 2018. Recall level: Level 2 Recall. Chongqing Sanfeng Medical Device Co., Ltd. initiated a voluntary Class II recall for its Vacuum Bloo

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Chongqing Sanfeng Medical Device Co., Ltd. voluntarily recalls
- Company Name: Chongqing Xinwen Medical Equipment Co., Ltd.
- Publication Date: 2018-10-30
- Product Name: Vacuum blood collection tubes
- Recall Level: Level 2 Recall
- Recall Reason: Product not sterilized
- Discovering Company: Chongqing Sanfeng Medical Equipment Co., Ltd.
- Manufacturing Company: Chongqing Xinwen Medical Equipment Co., Ltd.
- Summary: Chongqing Sanfeng Medical Device Co., Ltd. initiated a voluntary Class II recall for its Vacuum Blood Collection Tubes, specifically the 2.7ml Blood Coagulation Tube, due to a critical manufacturing oversight: the products were not sterilized. This issue affected batch number 1809-01, produced on September 25, 2018. Of the 35,344 units produced, 3,600 were distributed within Chongqing, China. The company reported this recall to the provincial Food and Drug Administration Department on September 30, 2018, operating under the regulatory framework of the National Medical Products Administration (NMPA). The recall was publicly announced on October 30, 2018. As required actions, Chongqing Sanfeng Medical Device Co., Ltd. promptly contacted its distributors and users to retrieve the non-compliant products. The company confirmed that all affected units were successfully recalled and had not been used, thereby preventing potential health risks associated with unsterilized medical devices. This swift action aligns with established medical device recall management protocols to ensure product safety and compliance.

Company: https://www.globalkeysolutions.net/companies/chongqing-xinwen-medical-equipment-co-ltd/22d3041b-7d39-4763-9510-a878faa151a8/