# China NMPA Product Recall - Implantable intravenous drug delivery system

Source: https://www.globalkeysolutions.net/records/china_product_recall/smiths-medical-asd-inc/0aebed6a-c4a5-44f9-bd73-6341045d69bb/
Source feed: China

> China NMPA product recall for Implantable intravenous drug delivery system by Smiths Medical ASD, Inc. published July 22, 2019. Recall level: Level 3 Recall. Smiths Medical ASD, Inc. initiated a voluntary Class III recall of its implantable intravenous drug 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Smiths Medical ASD, Inc. is voluntarily recalling its implantable intravenous drug delivery systems.
- Company Name: Smiths Medical ASD, Inc.
- Publication Date: 2019-07-22
- Product Name: Implantable intravenous drug delivery system
- Recall Level: Level 3 Recall
- Recall Reason: Smiths Medical has discovered that certain individual GRIPPER® needles in implantable intravenous drug delivery systems manufactured between June 11, 2018, and February 21, 2019, including needles supplied in the PORT-A-CATH tray, may be blocked or clogged. If a blockage is present in the needle, the product must be replaced before the procedure can continue, which may delay the start of treatment. Smiths Medical has not received any reports of death or serious injury as a result globally.
- Discovering Company: Smith Medical Devices (Beijing) Co., Ltd.
- Manufacturing Company: Smiths Medical ASD, Inc.
- Summary: Smiths Medical ASD, Inc. initiated a voluntary Class III recall of its implantable intravenous drug delivery systems, specifically PORT-A-CATH® trays with GRIPPER® needles. This recall, reported by Smiths Medical Devices (Beijing) Co., Ltd. to the National Medical Products Administration (NMPA) on July 8, 2019, addresses a critical issue: certain GRIPPER® needles manufactured between June 11, 2018, and February 21, 2019, may be blocked or clogged. While no deaths or serious injuries have been reported, this defect could significantly delay medical treatment as affected products would require immediate replacement during procedures. The recall impacts 79,764 units sold in China and has a global reach. Under the NMPA's regulatory requirements, Smiths Medical must issue emergency recall notices to distributors, instructing them to inform customers and facilitate the return of all affected product batches. Subsequently, all recalled implantable intravenous drug delivery systems are to be returned to Smiths Medical Devices (Beijing) Co., Ltd. for proper disposal, ensuring their complete removal from circulation and safeguarding patient care.

Company: https://www.globalkeysolutions.net/companies/smiths-medical-asd-inc/d899a4ea-b7fd-4d01-8d91-a1b5b5df9993/