# China NMPA Product Recall - QUADROX-iD Pediatric Oxygenator

Source: https://www.globalkeysolutions.net/records/china_product_recall/maquet-cardiopulmonary-ag/c0f8c915-5f9f-4b6b-b7f2-11fb6ee77e3f/
Source feed: China

> China NMPA product recall for QUADROX-iD Pediatric Oxygenator by MAQUET Cardiopulmonary AG published March 30, 2023. Recall level: Level 1 Recall. Maquet Cardiopulmonary GmbH initiated a voluntary Class I recall of its QUADROX-iD Pediatric Oxygena

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Maquet Cardiopulmonary GmbH has initiated a voluntary recall of its membrane oxygenators.
- Company Name: MAQUET Cardiopulmonary AG
- Publication Date: 2023-03-30
- Product Name: QUADROX-iD Pediatric Oxygenator
- Recall Level: Level 1 Recall
- Recall Reason: The sterile barrier of the membrane oxygenator may be damaged, and there may be deviations in the product coating.
- Discovering Company: Maikewei (Shanghai) Medical Equipment Co., Ltd.
- Manufacturing Company: MAQUET Cardiopulmonary AG
- Summary: Maquet Cardiopulmonary GmbH initiated a voluntary Class I recall of its QUADROX-iD Pediatric Oxygenator, reported by Maquet (Shanghai) Medical Equipment Co., Ltd. The recall, published by the National Medical Products Administration (NMPA) on March 30, 2023, stems from a review of non-compliance reports. Key issues identified include potential damage to the product's sterile barrier and potential deviations in the product coating. These defects could compromise product safety and efficacy, warranting the highest level of recall due to the potential for serious health consequences. The affected product is identified under National Medical Device Registration Certificate 20163102404. This action underscores the regulatory oversight by the NMPA to ensure medical device safety and quality. Detailed information regarding specific affected models is available in the 

Company: https://www.globalkeysolutions.net/companies/maquet-cardiopulmonary-ag/63ce4d48-8350-4a6e-bbe2-5003aa14ae22/