# 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/a31ff431-ff0a-435a-a266-72a8e6c00395/
Source feed: China

> China NMPA product recall for Disposable human arterial blood sample collection device by Radiometer Medical Equipment (Shanghai) Co., Ltd. published April 01, 2021. Recall level: Level 2 Recall. On April 1, 2021, the National Medical Products Administration (NMPA) announced a voluntary Class II

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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: 2021-04-01
- Product Name: Disposable human arterial blood sample collection device
- Recall Level: Level 2 Recall
- Recall Reason: PICO70 related issues with the product's sterile barrier system
- Discovering Company: Radiometer Medical Equipment (Shanghai) Co., Ltd.
- Manufacturing Company: Radiometer Medical Equipment (Shanghai) Co., Ltd.
- Summary: On April 1, 2021, the National Medical Products Administration (NMPA) announced a voluntary Class II recall initiated by Radomet Medical Devices (Shanghai) Co., Ltd. This action follows the discovery by Radomet Denmark of a potential issue with the sterile barrier system in certain batches of its PICO70 product, specifically the disposable human arterial blood sample collector (Registration Certificate No.: 国械注进 20173661699).

The core issue identified is a very low probability of a compromised sterile barrier, which is critical for medical devices designed for direct human contact and sample collection. A breach in this system could potentially affect product sterility, posing a risk to patient safety.

Operating under the oversight of the NMPA, Radomet Medical Devices (Shanghai) Co., Ltd. has taken the proactive measure to recall the affected devices. This voluntary recall, designated as Class II, indicates that the use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The company is required to provide detailed information on the specific models, specifications, and batch numbers of the affected products through a 'Medical Device Recall Event Report Form' to facilitate the recall process and ensure all potentially impacted products are removed from circulation. This action underscores the company's commitment to product safety and compliance with regulatory standards.

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