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

Source: https://www.globalkeysolutions.net/records/china_product_recall/cao-medical-equipment-co-ltd/407b51f3-f7d7-45e3-a942-89a701b422fe/
Source feed: China

> China NMPA product recall for Disposable human arterial blood sample collection device by CAO Medical Equipment Co., Ltd. published November 20, 2020. Recall level: Level 2. On November 20, 2020, the National Medical Products Administration (NMPA) announced a voluntary Clas

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Radomet Medical Devices (Shanghai) Co., Ltd. is voluntarily recalling its disposable human arterial blood sample collection devices.
- Company Name: CAO Medical Equipment Co., Ltd.
- Publication Date: 2020-11-20
- Product Name: Disposable human arterial blood sample collection device
- Recall Level: Level 2
- Recall Reason: The problem of corrosion caused by exposure of disposable human arterial blood sampling devices to corrosive chlorides.
- Discovering Company: Radiometer Medical Equipment (Shanghai) Co., Ltd.
- Manufacturing Company: CAO Medical Equipment Co., Ltd.
- Summary: On November 20, 2020, the National Medical Products Administration (NMPA) announced a voluntary Class II recall initiated by Radomet Medical Devices (Shanghai) Co., Ltd. The recall pertains to their Disposable Human Arterial Blood Sample Collectors, identified under Registration Certificate No. 20173661699. This action was prompted by a significant quality issue involving corrosion, specifically attributed to exposure to corrosive chlorides. The presence of such corrosion could potentially compromise the integrity and safe function of the medical devices, posing risks to patient health and sample accuracy. Under the oversight of the NMPA, with information sourced from the Shanghai Municipal Drug Administration Website, Radomet Medical Devices voluntarily undertook this recall to address the identified product defect. A Class II recall signifies that the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The company has directed stakeholders to a 'Medical Device Recall Event Report Form' for comprehensive details regarding the specific models, specifications, and batch numbers of the affected products. This voluntary recall underscores the regulatory framework's commitment to ensuring the safety and quality of medical devices distributed within China, and the company's responsibility in rectifying product deficiencies.

Company: https://www.globalkeysolutions.net/companies/cao-medical-equipment-co-ltd/fffe5828-92d5-4225-8981-290c69ddadd7/