# China NMPA Product Recall - Blood gas analyzer

Source: https://www.globalkeysolutions.net/records/china_product_recall/cao-medical-equipment-co-ltd/de8216d5-842a-4df7-b946-8da2397f6549/
Source feed: China

> China NMPA product recall for Blood gas analyzer by CAO Medical Equipment Co., Ltd. published March 16, 2020. Recall level: Level 2 Recall. Radomet Medical Equipment (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its blood ga

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Radomet Medical Equipment (Shanghai) Co., Ltd. is voluntarily recalling blood gas analyzers.
- Company Name: CAO Medical Equipment Co., Ltd.
- Publication Date: 2020-03-16
- Product Name: Blood gas analyzer
- Recall Level: Level 2 Recall
- Recall Reason: When the blood gas analyzer and its barcode scanner are in normal use, users may use barcodes without a check digit, which may pose a potential risk of misreading. In rare cases, this could lead to patient confusion or delay in medical treatment.
- Discovering Company: Radiometer Medical Equipment (Shanghai) Co., Ltd.
- Manufacturing Company: CAO Medical Equipment Co., Ltd.
- Summary: Radomet Medical Equipment (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its blood gas analyzers and their associated scanners, as reported on March 16, 2020, by the National Medical Products Administration (NMPA). The recall stems from a critical issue where the devices may process barcodes lacking a check digit. This flaw carries a potential risk of misreading patient data, which could lead to patient confusion or, in rare instances, delay necessary medical treatment. The company proactively identified this concern during normal product use and decided to recall the affected medical devices. This action falls under the regulatory oversight of the NMPA and the Shanghai Municipal Drug Administration. The specific models, specifications, and batches involved in this recall are detailed in the accompanying Medical Device Recall Event Report Form. This voluntary recall underscores the company's commitment to patient safety and adherence to regulatory standards.

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