FDA Reports Recall of 0.9% Sodium Chloride for Injection USP 250 ml in Excel Because of Fluid Leakage or Low Fill Volume
On March 3, 2022, the U.S. Food and Drug Administration (FDA) reported (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/b-braun-medical-inc-issues-voluntary-nationwide-recall-09-sodium-chloride-injection-usp-250ml-excel) B. Braun Medical’s voluntary recall of five lots of 0.9% sodium chloride for injection USP 250 ml in Excel within the United States at the hospital and user levels after receiving reports of fluid leakage or low fill volumes.
According to FDA, the biggest risk with a slow leak in any IV solution preparation is a break in sterility, which poses a risk for the patient being exposed to a bacterial or fungal infection that could lead to bloodstream infection. FDA reported that B. Braun Medical has not received any reports of adverse events related to the recall.
The product is indicated for extracellular fluid replacement, treatment of metabolic alkalosis in the presence of fluid loss, mild sodium depletion, and use as a priming solution in hemodialysis procedures or to initiate and terminate blood transfusions without hemolyzing red blood cells.
The recall affects the following lots of 0.9% sodium chloride for injection USP in Excel, product catalog number L8002, shipped to U.S. distributors:
|
Lot Number |
National Drug Code |
Distribution Date Range |
Expiration Date |
|
J1E086 |
0264-7800-20 |
June 15–July 22, 2021 |
May 31, 2023 |
|
J1E204 |
0264-7800-20 |
June 17–July 21, 2021 |
May 31, 2023 |
|
J1E213 |
0264-7800-20 |
June 2–June 28, 2021 |
May 31, 2023 |
|
J1H137 |
0264-7800-20 |
July 14–October 20, 2021 |
June 30, 2023 |
|
J1H138 |
0264-7800-20 |
July 14–October 29, 2021 |
June 30, 2023 |
FDA reported that B. Braun Medical is notifying its distributors and customers with an official recall notice and arranging for the return of all recalled products. Facilities that have the recalled product should discontinue use and contact B. Braun Medical’s customer support department to arrange its return.
Patients and consumers with questions regarding the recall can contact B. Braun Medical at 800-227-2862, Monday–Friday, from 8 am–6 pm ET.
Healthcare professionals and consumers should report any adverse reactions or quality problems (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm) they experienced using the product to MedWatch, FDA’s Safety Information and Adverse Event Reporting Program.