Recall - B. Braun (0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container) produced by B. Braun Medical Inc. - Presence of particulate matter identified as zinc[...]

Summary

Company Announcement

FOR IMMEDIATE RELEASE - August 19, 2026- Bethlehem, PA, B. Braun Medical Inc (B. Braun) is voluntarily 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 bloodcells). To date there have been no reports of serious injury, death or other adverse events associated with this issue.

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.

The recalled product can be identified as follows:

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 to place of purchase.

Consumers with questions regarding this recall can contact B. Braun by emailing [email protected], 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.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
• 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.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.