# China NMPA Product Recall - Quartz Equipment Catheter Dynamic Pressure Detector

Source: https://www.globalkeysolutions.net/records/china_product_recall/st-jude-medical-supplies-shanghai-co-ltd/8fe11e17-461d-4297-b041-ab7f050fcabe/
Source feed: China

> China NMPA product recall for Quartz Equipment Catheter Dynamic Pressure Detector by St. Jude Medical Supplies (Shanghai) Co., Ltd. published September 06, 2023. Recall level: Level 3 Recall. St. Jude Medical, distributed by Abbott Medical Products (Shanghai) Co., Ltd., has initiated a volun

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: St. Jude Medical is voluntarily recalling its catheter dynamic pressure monitoring system.
- Company Name: St. Jude Medical Supplies (Shanghai) Co., Ltd.
- Publication Date: 2023-09-06
- Product Name: Quartz Equipment Catheter Dynamic Pressure Detector
- Recall Level: Level 3 Recall
- Recall Reason: Some serial numbered products did not come with a paper product manual.
- Discovering Company: Abbott Medical (Shanghai) Co., Ltd.
- Manufacturing Company: St. Jude Medical Supplies (Shanghai) Co., Ltd.
- Summary: St. Jude Medical, distributed by Abbott Medical Products (Shanghai) Co., Ltd., has initiated a voluntary Class III recall for its Quartz Equipment Catheter Dynamic Pressure Monitor. The recall was publicly announced by the National Medical Products Administration (NMPA) on September 6, 2023. The primary reason for this action is the discovery that some products, identified by specific serial numbers, lack the required paper product instructions. This oversight means that users may not have immediate access to critical operational and safety information typically provided in the physical documentation. As a Class III recall, it indicates a situation where there is a low probability that the use of, or exposure to, a violative product will cause adverse health consequences. St. Jude Medical is responsible for manufacturing the device, which holds the National Medical Device Registration Certificate 20163073092. The company is taking proactive steps to address the documentation deficiency, ensuring compliance with regulatory standards and the safe use of its medical devices. Detailed information regarding affected models, specifications, and batch numbers is available in the accompanying Medical Device Recall Event Report Form.

Company: https://www.globalkeysolutions.net/companies/st-jude-medical-supplies-shanghai-co-ltd/7c5b9a04-c4d8-48bc-9057-962fc4da8a70/