# China NMPA Product Recall - Catheter dynamic pressure monitoring device

Source: https://www.globalkeysolutions.net/records/china_product_recall/abbott-medical-shanghai-co-ltd/a2459911-47f4-4c8d-94ad-8d7d914a8f50/
Source feed: China

> China NMPA product recall for Catheter dynamic pressure monitoring device by Abbott Medical (Shanghai) Co., Ltd. published April 28, 2019. Recall level: Level 3. Abbott Medical Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its Catheter 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Abbott Medical (Shanghai) Co., Ltd. is voluntarily recalling its catheter dynamic pressure monitoring device.
- Company Name: Abbott Medical (Shanghai) Co., Ltd.
- Publication Date: 2019-04-28
- Product Name: Catheter dynamic pressure monitoring device
- Recall Level: Level 3
- Recall Reason: The issue involves the product failing to maintain continuous communication with the display workstation, resulting in intermittently displaying pressure to the doctor.
- Discovering Company: Abbott Medical (Shanghai) Co., Ltd.
- Manufacturing Company: Abbott Medical (Shanghai) Co., Ltd.
- Summary: Abbott Medical Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its Catheter Dynamic Pressure Monitor (Registration Certificate No.: 20163213092) on April 28, 2019. This action was reported to the National Medical Products Administration (NMPA) and involved products registered under the Shanghai Food and Drug Administration.
The recall stems from a significant product malfunction where the device fails to maintain continuous communication with its display workstation. This issue leads to the intermittent display of critical pressure readings, potentially impacting medical professionals' ability to monitor patients effectively. The company's proactive recall aims to address this performance deficiency.
While specific inspection dates are not detailed in this report, the recall announcement on April 28, 2019, signifies the company's response to identifying this critical defect. Abbott Medical Products (Shanghai) Co., Ltd. is responsible for providing detailed information on affected models, specifications, and batch numbers through a "Medical Device Recall Event Report Form." This recall emphasizes the importance of device reliability and regulatory oversight by authorities such as the NMPA in ensuring product safety and performance in the medical device sector.

Company: https://www.globalkeysolutions.net/companies/abbott-medical-shanghai-co-ltd/c4208c4e-424f-4bd5-9c27-c8d650c64287/