- The recall covers one lot of B. Braun Excel Lactated Ringers Injection, 1000mL: lot J4H077, catalog number L7500 and NDC 0264-7750-00.
- The affected product has an expiration date of Nov. 30, 2026.
- Particulate matter was identified primarily as cellulose cotton fibers, with individual particles identified as cellulose wood fiber and polystyrene.
- B. Braun said it had received no reports of adverse events related to the recall as of its Aug. 19 announcement.
- The company is arranging for the return and replacement of recalled products and advises customers with affected product to return it to the place of purchase.
- The FDA notice specifically provides a reporting pathway for adverse reactions or quality problems involving off-label use of the product in animal or veterinary patients.
B. Braun Medical Inc. has issued a voluntary North American recall of one lot of its Excel Lactated Ringers Injection, 1000mL, because of particulate matter found in the solution.
According to the company’s Aug. 19, 2026, recall announcement posted by the U.S. Food and Drug Administration, the particles were identified primarily as cellulose cotton fibers. Individual particles were also identified as cellulose wood fiber and polystyrene.
The recall is being conducted at the hospital and healthcare facility level and involves product distributed nationwide in the United States and to Canada between Aug. 29 and Sept. 30, 2024.
What it means for veterinary teams
Veterinary professionals who have Excel Lactated Ringers Injection in inventory should check the product information against the recalled lot, particularly if the product is being used off label in animal patients.
The affected product is B. Braun Excel Container Lactated Ringers Injection, 1000mL, lot J4H077, with catalog number L7500, NDC 0264-7750-00 and an expiration date of Nov. 30, 2026.
Customers with recalled product are instructed to return it to the place of purchase. B. Braun is notifying distributors and customers by mail and arranging for the return and replacement of affected products.
The FDA notice also states that adverse reactions or quality problems associated with off-label use of the product in animal or veterinary patients may be reported to the agency through its animal adverse-event reporting system.
Potential risks from particulate matter
According to B. Braun’s risk statement, use of the affected product has a reasonable probability of causing pulmonary emboli, or blockages in pulmonary blood vessels, as well as occlusion of other blood vessels that could result in tissue death and possible organ damage.
Other potential effects identified by the company include phlebitis, systemic immune activation, organ dysfunction and hemolysis.
B. Braun reported that it had not received any adverse-event reports associated with the recall as of the announcement.
Product used for hydration and fluid replacement
Lactated Ringers Injection is used as a source of water and electrolytes for hydration and fluid replacement. According to the recall announcement, the affected B. Braun product is packaged in a non-PVC, non-DEHP flexible container system.
Customers with questions about the recall can contact B. Braun at recalls@bbraunusa.com from 8 a.m. to 5 p.m. EST, Monday through Friday.
The recall is being conducted with the knowledge of the FDA.
Information sourced from B. Braun Medical Inc.’s recall announcement posted by the U.S. Food and Drug Administration.
