MedWatch - The FDA Safety Information and Adverse Event Reporting Program
TOPIC: 0.9% Sodium Chloride for Injection USP, 250 mL in Excel by B. Braun Medical: Recall - Due to Fluid Leakage or Low Fill Volume
AUDIENCE: Patient, Health Professional, Risk Manager, Pharmacy
ISSUE: B. Braun Medical is recalling five (5) lots of 0.9% Sodium Chloride for Injection USP, 250 mL in Excel within the United States to the hospital/user level. The voluntary recall has been initiated due to fluid leakage or low fill volume of the respective containers. The biggest risk with a slow leak in any intravenous solution preparation is a break in sterility which poses a risk for the patient being exposed to a bacterial or fungal infection. There is a remote probability this could lead to bloodstream infection. B. Braun has not received any reports of adverse events related to this recall. For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: 0.9% Sodium Chloride for Injection USP in Excel is indicated for extracellular fluid replacement, treatment of metabolic alkalosis in the presence of fluid loss and mild sodium depletion. 0.9% Sodium Chloride Injection USP in Excel is also indicated for use as a priming solution in hemodialysis procedures and may be used to initiate and terminate blood transfusions without hemolyzing red blood cells. RECOMMENDATIONS:
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Facilities and distributors that have product which is being recalled should discontinue use immediately and contact B. Braun Medical.
Facilities with questions regarding this recall can contact B. Braun by phone.
Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report online.
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.