Safety Report: B. Braun Medical Inc. 0.9% Sodium Chloride for Injection USP 250ML in Excel - recalled due to Fluid Leakage, USA

United States

B. Braun Medical Inc. (B. Braun) is voluntarily recalling five (5) lots of 0.9% Sodium Chloride for Injection USP 250ML in Excel within the United States to the hospital/user level. 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.

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. The list of recalled products can be found on the link below

B. Braun is notifying its distributors and customers by an official recall notice sent via certified registered mail and is arranging for the return of all recalled products. Facilities and distributors that have product which is being recalled should discontinue use immediately.

Company name: B. Braun Medical Inc.
Brand name: B. Braun Medical Inc.
Product recalled: 0.9% Sodium Chloride for Injection USP 250ML in Excel
Reason of the recall: Fluid leakage and low fill volume may cause a lack in sterility
FDA Recall date: March 03, 2022

Check the full recall details including the list of the recalled products on www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/b-braun-medical-inc-issues-voluntary-nationwide-recall-09-sodium-chloride-injection-usp-250ml-excel

Source: FDA