FDA Discretion for Solution Batches
FDA Discretion for Solution Batches
In alignment with the FDA, Baxter released four lots of IV fluid bags that were manufactured at North Cove prior to Hurricane Helene. These lots were released the week of December 2, 2024. If you have questions about whether your facility will have these products, please contact your local Baxter sales representative.
A very small proportion of these products have been associated with leaks, which are currently under investigation to mitigate quality concerns. Because there are just a small number of bags in each impacted lot that may experience this defect, these lots are being released with instructions for health care professionals to screen the bags for leaks prior to use, and to discard IV fluid bags that have any evidence of leakage. Dear Healthcare Professional (DHCP) letters for each of lots associated can be found below.
While healthcare practitioners should continue to use their professional judgement in assessing the needs and resources of their individual organizations and patients, this site is intended to help support product management and efforts. Our Medical Affairs team is also available at [email protected].
DHCP Letters for Solutions with FDA Discretion
Baxter U.S. Medical Information Online: https://medinfo.baxter.com
Self-service portal intended for Healthcare Professionals to search and download frequently requested product information.