Temporary Importation of Sodium Chloride for Irrigation

This document is a communication from Baxter Healthcare Corporation regarding the temporary importation of Sodium Chloride 0.9% for Irrigation from the United Kingdom. The importation is coordinated with the U.S. Food and Drug Administration (FDA) to address drug shortages of irrigation products. The document specifies that the imported product has not received FDA approval and outlines the conditions under which it is being imported. It includes important prescribing information for healthcare professionals, detailing the product's compatibility with existing urology irrigation sets and the need for visual inspection of the bags for defects. The document also highlights key differences between the FDA-approved product and the imported version, including labeling and storage conditions. Additionally, it provides contact information for reporting adverse events or quality issues associated with the product, as well as instructions for placing orders. The communication is signed by a senior executive at Baxter Healthcare Corporation.