FDA MedWatch - 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB Container by B. Braun Medical

If your email program has trouble displaying this email, view as a webpage.

TOPIC: 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB Container by B. Braun Medical: Recall - Due to the Presence of Particulate Matter

AUDIENCE: Patient, Health Care Professional, Risk Manager, Pharmacy, Hematology, Cardiology

ISSUE: B. Braun Medical is recalling three (3) lots of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB Container, to the hospital/healthcare facility/user level due to presence of particulate matter identified as zinc oxide.

Risk Statement: Administration of 0.9% Sodium Chloride Injection USP, found to contain particulate matter, has a reasonable probability of causing life-threatening adverse health consequences including pulmonary emboli (blockage in pulmonary blood vessels), occlusions of other blood vessels (which can lead to tissue death and possible organ damage), and/or phlebitis (inflammation of the walls of veins, which may lead to clotting). Systemically, foreign particles infused intravenously can cause systemic activation of the immune system, organ dysfunction, and hemolysis (breakdown of blood cells).

The product was distributed Nationwide to hospital and healthcare facilities from February 27, 2026 to August 3, 2026.

To date there have been no reports of serious injury, death or other adverse events associated with this issue.

For more information about this recall, click on the red button "Read Recall" below.

BACKGROUND: 0.9% Sodium Chloride Injection USP, 100 mL is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration and is packaged in non-PVC, non-DEHP flexible container system. This product is designed for use as a diluent and delivery system for intermittent intravenous administration of compatible drug additives.

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. 

• Consumers with questions regarding this recall can contact B. Braun by emailing recalls@bbraunusa.com.

Health care 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.

Follow us on X at @FDAMedWatch