# China NMPA Product Recall - AFFINITY PIXIE Oxygenation System (Pediatric Oxygenation System)

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-inc/a268164f-0928-4056-98a2-db9ba7310c00/
Source feed: China

> China NMPA product recall for AFFINITY PIXIE Oxygenation System (Pediatric Oxygenation System) by Medtronic Inc. published December 30, 2021. Recall level: Level 3 Recall. The National Medical Products Administration (NMPA) issued an announcement on December 30, 2021, reg

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic Inc. is voluntarily recalling its AFFINITY PIXIE Oxygenation System for children.
- Company Name: Medtronic Inc.
- Publication Date: 2021-12-30
- Product Name: AFFINITY PIXIE Oxygenation System (Pediatric Oxygenation System)
- Recall Level: Level 3 Recall
- Recall Reason: Regarding specific models and batches of products, Medtronic failed to properly track and control the change control of its supplier, Qosina.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic Inc.
- Summary: The National Medical Products Administration (NMPA) issued an announcement on December 30, 2021, regarding a Class III voluntary recall initiated by Medtronic Inc. for its AFFINITY PIXIE Oxygenation System. The recall was reported by Medtronic (Shanghai) Management Co., Ltd. The primary reason for this action was Medtronic's failure to properly track and control the change management processes of its supplier, Qosina, concerning specific models and batches of the oxygenation system. This regulatory oversight indicates a gap in the company's quality management system, specifically in its ability to ensure that changes implemented by suppliers are adequately reviewed, documented, and controlled to maintain product integrity and safety. The regulatory framework governing this action is established by the NMPA, which oversees medical device safety and quality in China. The required action is a voluntary recall, signifying Medtronic's proactive measure to address the identified deficiency. While no specific inspection dates are mentioned, the recall announcement on December 30, 2021, highlights the issue's discovery and subsequent action. The recall emphasizes the critical importance of robust supplier change control within the medical device industry to safeguard patient health and ensure compliance with stringent national and international quality standards. Further details regarding affected product specifications and batches are available in the "Medical Device Recall Event Report Form" provided by the manufacturer.

Company: https://www.globalkeysolutions.net/companies/medtronic-inc/398d5f72-c7d2-4c97-94fc-fbef4cf2336d/