# China NMPA Product Recall - Disposable - BARD® MARQUEE® Disposable Core Biopsy Instrument

Source: https://www.globalkeysolutions.net/records/china_product_recall/bard-peripheral-vascular-inc/bf41914a-65a2-4b2c-81bb-73a66637ba8c/
Source feed: China

> China NMPA product recall for Disposable - BARD® MARQUEE® Disposable Core Biopsy Instrument by Bard Peripheral Vascular, Inc. published October 17, 2024. Recall level: Level 2 Recall. The National Medical Products Administration (NMPA) announced a Level II voluntary recall on October

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Bard Peripheral Vascular, Inc. has initiated a voluntary recall of products including disposable integrated biopsy needles.
- Company Name: Bard Peripheral Vascular, Inc.
- Publication Date: 2024-10-17
- Product Name: Disposable - BARD® MARQUEE® Disposable Core Biopsy Instrument
- Recall Level: Level 2 Recall
- Recall Reason: When the trigger is pressed, the inner needle rod is ejected.
- Discovering Company: Bard Medical Technology (Shanghai) Co., Ltd.
- Manufacturing Company: Bard Peripheral Vascular, Inc.
- Summary: The National Medical Products Administration (NMPA) announced a Level II voluntary recall on October 17, 2024, initiated by Bard Peripheral Vascular, Inc. The recall addresses a critical manufacturing defect in disposable BARD® MARQUEE® Core Biopsy Instruments (NMPA Registration Certificates 20202140405 and 20202140429). The primary issue identified is the premature ejection of the inner needle rod when the trigger is activated, posing a potential safety risk during medical procedures. Bard Medical Technology (Shanghai) Co., Ltd. reported this defect. Under the NMPA's regulatory guidelines, a Level II recall indicates that the product's use could lead to temporary or reversible adverse health consequences, or that serious consequences are remote. A key detail of this action is that the specific batches of affected products were not imported into China, thereby limiting any direct domestic impact. Further information regarding specific models and batches is available in the attached 'Medical Device Recall Event Report'.

Company: https://www.globalkeysolutions.net/companies/bard-peripheral-vascular-inc/12056f40-c9c7-45e9-b305-900ec162d183/