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

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.