# China NMPA Product Recall - Implantable intravenous drug delivery system

Source: https://www.globalkeysolutions.net/records/china_product_recall/smiths-medical-asd-inc/f6688251-8fa6-40d3-a3c8-b9997fc03897/
Source feed: China

> China NMPA product recall for Implantable intravenous drug delivery system by Smiths Medical ASD, Inc. published July 15, 2019. Recall level: Level 3. Smiths Medical ASD, Inc., through its local agent Smiths Medical Devices (Beijing) Co., Ltd., initia

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Smiths Medical ASD, Inc. is issuing a voluntary recall of its implantable intravenous drug delivery systems.
- Company Name: Smiths Medical ASD, Inc.
- Publication Date: 2019-07-15
- Product Name: Implantable intravenous drug delivery system
- Recall Level: Level 3
- 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 certain PORT-A-CATH trays, may be blocked or clogged. If a blockage is present in the needle, the product must be replaced before proceeding with the procedure. This may delay the initiation of treatment. Smiths Medical has not received any reports of death or serious injury as a result of this recall globally. This is a voluntary recall.
- Discovering Company: Smith Medical Devices (Beijing) Co., Ltd.
- Manufacturing Company: Smiths Medical ASD, Inc.
- Summary: Smiths Medical ASD, Inc., through its local agent Smiths Medical Devices (Beijing) Co., Ltd., initiated a voluntary Class III recall of certain implantable intravenous drug delivery systems. This recall, formally reported to the National Medical Products Administration (NMPA) on July 8, 2019, and published on July 15, 2019, addresses an issue with GRIPPER® needles manufactured between June 11, 2018, and February 21, 2019. The primary concern is that individual needles within these systems may be blocked or clogged, which would necessitate product replacement and could delay the commencement of patient treatment. Although no deaths or serious injuries have been reported globally due to this issue, the company emphasizes patient safety. The affected products, bearing National Medical Device Registration Certificate 20173661683, totaled 79,764 units sold in China. As part of the corrective action, Smiths Medical instructed distributors to issue emergency recall notices to their customers and arrange for the return of all implicated products to Smiths Medical Devices (Beijing) Co., Ltd. for proper disposal, ensuring compliance with NMPA regulations.

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