# China NMPA Product Recall - Disposable precision-adjustable infusion sets; extension tubing with flow regulator; three-way stopcock.

Source: https://www.globalkeysolutions.net/records/china_product_recall/baxter-medical-supplies-trading-shanghai-co-ltd/b54f8166-76c1-4186-b58f-e1c70e474c36/
Source feed: China

> China NMPA product recall for Disposable precision-adjustable infusion sets; extension tubing with flow regulator; three-way stopcock. by Baxter Medical Supplies Trading (Shanghai) Co., Ltd. published November 03, 2021. Recall level: Level 3 Recall. On November 3, 2021, Baxter Medical Products Trading (Shanghai) Co., Ltd. initiated a voluntary Clas

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Baxter Medical Supplies Trading (Shanghai) Co., Ltd. is voluntarily recalling the single-use precision adjustable infusion set Control-A-Flo set with injection site; extension tubing with flow regulator; and three-way stopcock.
- Company Name: Baxter Medical Supplies Trading (Shanghai) Co., Ltd.
- Publication Date: 2021-11-03
- Product Name: Disposable precision-adjustable infusion sets; extension tubing with flow regulator; three-way stopcock.
- Recall Level: Level 3 Recall
- Recall Reason: Upon product arrival and inspection, it was discovered that the product labels did not display the approved 59-month expiry date. To ensure consistency with the approved information, Baxter initiated this recall.
- Discovering Company: Baxter Medical Supplies Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Baxter Medical Supplies Trading (Shanghai) Co., Ltd.
- Summary: On November 3, 2021, Baxter Medical Products Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall concerning several medical devices. The affected products include single-use precision adjustable infusion sets, extended infusion tubing with flow regulators, and three-way stopcocks. This action was prompted by an internal review upon product arrival and inspection, which revealed discrepancies between the product labels' expiration dates and the officially approved 59-month shelf life. The recall was conducted under the regulatory framework of the National Medical Products Administration (NMPA) to ensure all product information aligns with registered details, as referenced by their respective National Medical Device Registration Certificates. Baxter's required action was to recall the specified batches to ensure consistency with approved information. Crucially, the company confirmed that the impacted product batches had not been commercially sold or distributed, meaning the recall does not affect normal use by end-users.

Company: https://www.globalkeysolutions.net/companies/baxter-medical-supplies-trading-shanghai-co-ltd/6683d881-f097-4ad4-8c0e-86927dfa203a/