# China NMPA Product Recall - Disposable intravenous nutrition infusion bags

Source: https://www.globalkeysolutions.net/records/china_product_recall/baxter-healthcare-corporation/36295358-856a-43ef-b784-b0145f758340/
Source feed: China

> China NMPA product recall for Disposable intravenous nutrition infusion bags by Baxter Healthcare Corporation published December 25, 2018. Recall level: Level 3. Baxter Healthcare Corporation, through its agent Baxter Medical Supplies Trading (Shanghai) Co., Ltd

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Baxter Healthcare Corporation voluntarily recalls single-use intravenous nutrition bags.
- Company Name: Baxter Healthcare Corporation
- Publication Date: 2018-12-25
- Product Name: Disposable intravenous nutrition infusion bags
- Recall Level: Level 3
- Recall Reason: The affected batches of products, when used to fill medications, may cause leakage. (The recall occurred overseas; domestically, it is not affected.)
- Discovering Company: Baxter Medical Supplies Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Baxter Healthcare Corporation
- Summary: Baxter Healthcare Corporation, through its agent Baxter Medical Supplies Trading (Shanghai) Co., Ltd., initiated a voluntary Class III recall of its disposable intravenous nutrition infusion bags. This action was reported to the National Medical Products Administration (NMPA) on December 10, 2018, and publicly announced on December 25, 2018. The main issue prompting the recall was the potential for product leakage when the infusion bags are used to fill medications, affecting product models H939737 and H938738. This voluntary recall operates under the NMPA's regulatory framework, referencing National Medical Device Registration Certificate No. 20153662931. While the recall impacted international markets such as Brazil, Chile, Uruguay, Puerto Rico, New Zealand, the United States, Canada, and Hong Kong, it explicitly did not involve the Chinese market. Consequently, no domestic actions or corrective measures were required within China.

Company: https://www.globalkeysolutions.net/companies/baxter-healthcare-corporation/8501ed99-7e58-4715-bb3b-510947efca69/