China NMPA Product Recall - QUADROX-iD Pediatric Oxygenator

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