Recall - B. Braun (Excel® Lactated Ringers Injection, 1000mL) produced by (B. Braun) - Presence of particulate matter identified primarily as cellulose cotton fibers, with[...]

Summary

Company Announcement

FOR IMMEDIATE RELEASE - August 19, 2026- Bethlehem, PA, B. Braun Medical Inc (B. Braun), is voluntarily recalling one lot of Excel® Lactated Ringers Injection, 1000mL to the hospital/healthcare facility level, due to the presence of particulate matter in solution identified primarily as cellulose cotton fibers, with individual particles also identified as cellulose wood fiber and polystyrene.

Risk Statement: The use of the defective product has a reasonable probability of causing 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). To date, B. Braun has not received any reports of adverse events related to this recall.

The product is used as a source of water and electrolytes for hydration and fluid replacement and may be administered to adult, pediatric and neonatal patients based on clinical need and is packaged in non-PVC, non-DEHP flexible container system. Product was distributed Nationwide and to Canada to hospitals and healthcare facilities from August 29, 2024, through September 30, 2024.

The recalled product can be identified as follows:

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 in an off label manner for animal/veterinary patients may be reported to the FDA online at http://www.FDA.gov/reportanimalAE

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