# 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/ba44a2c2-d0e8-426d-9785-e17928624e4a/
Source feed: China

> China NMPA product recall for Disposable human arterial blood sample collection device by Radiometer Medical Equipment (Shanghai) Co., Ltd. published July 04, 2019. Recall level: Level 2 Recall. The National Medical Products Administration (NMPA) announced a voluntary recall on July 4, 2019, co

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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: 2019-07-04
- 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 individual needles, which, in extremely rare cases, could lead to bloodstream infection and organ damage due to rust particles.
- Discovering Company: Radiometer Medical Equipment (Shanghai) Co., Ltd.
- Manufacturing Company: Radiometer Medical Equipment (Shanghai) Co., Ltd.
- Summary: The National Medical Products Administration (NMPA) announced a voluntary recall on July 4, 2019, concerning disposable human arterial blood sample collectors. The document does not explicitly identify the company responsible for initiating this recall; however, it references a Shanghai Food and Drug Administration Medical Device Registration Certificate, indicating the product's origin or registration jurisdiction. The central issue prompting this recall stems from a modification to the product design, specifically "reducing the number of needles on the product." While the detailed rationale or the precise implications for user safety or product efficacy are not elaborated, this design change necessitated a voluntary recall action by the manufacturer. The NMPA serves as the overarching regulatory body overseeing such medical device recalls in China, ensuring compliance and public health protection. Required actions include the execution of the voluntary recall itself and the submission of a Medical Device Recall Event Report Form, a standard procedure for documenting and managing such regulatory events. This indicates the manufacturer's responsibility to address the identified product characteristic, likely through product modification and adherence to regulatory reporting standards to mitigate potential risks associated with the design change.

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