B. Braun Issues Voluntary Nationwide Recall of 0.9% Sodium Chloride Injection Due to Zinc Oxide Particulate Contamination
核心洞察
B. Braun Medical Inc. is voluntarily recalling three lots of 0.9% Sodium Chloride Injection USP (搜索), 100 mL, in 150 mL PAB containers due to particulate matter identified as zinc oxide.
Administration of the contaminated solution carries a reasonable probability of life-threatening consequences, including pulmonary emboli, vascular occlusions, phlebitis, and systemic immune activation.
The affected product was distributed nationwide to hospitals and healthcare facilities from February 27, 2026 to August 3, 2026, with no reports of serious injury or death to date.
B. Braun Medical Inc. (B. Braun) is voluntarily recalling three lots of 0.9% Sodium Chloride Injection USP (搜索), 100 mL, in a 150 mL PAB Container to the hospital/healthcare facility/user level due to the presence of particulate matter identified as zinc oxide. The recall, announced August 19, 2026 from the company's headquarters in Bethlehem, PA, is being conducted with the knowledge of the U.S. Food and Drug Administration.
The product is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration, and is packaged in a non-PVC, non-DEHP flexible container system. It is designed for use as a diluent and delivery system for intermittent intravenous administration of compatible drug additives.
Clinical Risk Assessment
Administration of 0.9% Sodium Chloride Injection USP (搜索) found to contain particulate matter has a reasonable probability of causing life-threatening adverse health consequences. According to the company's risk statement, these include pulmonary emboli (blockage in pulmonary blood vessels), occlusions of other blood vessels—which can lead to tissue death and possible organ damage—and phlebitis (inflammation of the walls of veins, which may lead to clotting).
Systemically, foreign particles infused intravenously can cause activation of the immune system, organ dysfunction, and hemolysis (breakdown of blood cells). To date, B. Braun reports there have been no reports of serious injury, death, or other adverse events associated with this issue.
Recall Scope and Distribution
The recalled product was distributed nationwide to hospital and healthcare facilities from February 27, 2026 to August 3, 2026. B. Braun is notifying its distributors and customers by mail and is arranging for return and replacement of all recalled products. Customers that have the recalled product should return it to the place of purchase.
Reporting and Contact Information
Consumers with questions regarding this recall can contact B. Braun by emailing recalls@bbraunusa.com, Monday to Friday 8:00am to 5:00pm EST. 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.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. Reports can be submitted online at www.fda.gov/medwatch/report.htm, or by downloading a form at www.fda.gov/MedWatch/getforms.htm or calling 1-800-332-1088 to request a reporting form, then submitting by fax to 1-800-FDA-0178.