# China NMPA Product Recall - Disposable human arterial blood sample collection device

Source: https://www.globalkeysolutions.net/records/china_product_recall/radiometer-medical-equipment-shanghai-co-ltd/153a4d65-85ca-4a65-9522-7108c7def07e/
Source feed: China

> China NMPA product recall for Disposable human arterial blood sample collection device by Radiometer Medical Equipment (Shanghai) Co., Ltd. published December 05, 2018. Recall level: Level 2 Recall. Redomit Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its Disposable

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Radiometer Medical Devices (Shanghai) Co., Ltd. is voluntarily recalling its disposable human arterial blood sample collection devices.
- Company Name: Radiometer Medical Equipment (Shanghai) Co., Ltd.
- Publication Date: 2018-12-05
- Product Name: Disposable human arterial blood sample collection device
- Recall Level: Level 2 Recall
- Recall Reason: The product in question has been reported to have rust spots on the needles, which could potentially lead to blood infections and organ damage due to the rust particles.
- Discovering Company: Radiometer Medical Equipment (Shanghai) Co., Ltd.
- Manufacturing Company: Radiometer Medical Equipment (Shanghai) Co., Ltd.
- Summary: Redomit Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its Disposable Human Arterial Blood Sample Collectors. This action was prompted by the discovery of rust spots on the needles of the affected products. The presence of these rust spots poses a significant health risk, as it may lead to severe complications, including blood infection and organ damage resulting from the introduction of rust particles into the patient's bloodstream during use. The National Medical Products Administration (NMPA) oversees this recall, as indicated by the official reporting and publication on their platform on December 5, 2018. While specific inspection dates are not provided in the document, the company reported the issue and took prompt action. Redomit Medical Devices (Shanghai) Co., Ltd. is required to manage this recall, providing further details on affected product models and batches in a Medical Device Recall Event Report Form. This measure ensures patient safety and adherence to medical device quality standards.

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