B. Braun Medical Inc. has announced a voluntary nationwide medical product recall for two specific lots of its Lactated Ringer’s Injection, E7500, 1L. The recall, initiated on April 28, 2026, is due to the presence of particulate matter found within the solution, according to the U.S. Food and Drug Administration (FDA).
Lactated Ringer’s Injection is commonly used in both adult and paediatric patients as a source of electrolytes and water for hydration. The presence of foreign particles in such a solution can pose significant health risks.
Details of the Medical Product Recall
The affected products are Lactated Ringer’s Injection, E7500, 1L, supplied sterile and nonpyrogenic in plastic containers. B. Braun Medical Inc. identified the issue through customer complaints, with investigations revealing the particulates to be primarily cellulose and stearates, alongside trace amounts of inorganic materials such as copper.
The specific lots subject to this medical product recall are:
- Lot Number: E3J4P7561
- Distribution Range: November 2024 – March 2025
- Expiration Date: May 31, 2027
- Lot Number: E3J4S843
- Distribution Range: January 2025 – May 2025
- Expiration Date: May 31, 2027
These products can be identified by product code E7500 or NDC 0264-7750-07. Distribution occurred nationwide across the United States to distributors, hospitals, and various healthcare facilities.
Potential Health Risks Associated with Particulate Matter
While B. Braun Medical Inc. has not received reports of adverse events directly linked to this recall to date, the potential for patient harm is considerable if the affected product is administered. The FDA highlights several serious risks:
- Pulmonary Emboli: Blockages in the blood vessels of the lungs.
- Occlusions of Other Blood Vessels: This can lead to tissue death (necrosis) and potential organ damage.
- Phlebitis: Inflammation of vein walls, which may result in blood clotting.
- Systemic Reactions: Intravenously infused foreign particles can activate the immune system, potentially causing organ dysfunction and hemolysis (the breakdown of red blood cells).
These complications may necessitate additional medical intervention, and in severe cases, could lead to permanent impairment or even be life-threatening.
Guidance for Healthcare Facilities and Patients
B. Braun is actively notifying its distributors and customers by mail to facilitate the return of all recalled products. Healthcare facilities and distributors in possession of the recalled lots should cease use immediately and follow the company’s instructions for product return, utilising the provided Urgent Pharmaceutical Recall Acknowledgement form.
Consumers who may have questions regarding this recall can contact B. Braun’s Recalls Department directly at 844-903-6417 or via email at recalls@bbraunusa.com, Monday to Friday, 8:00 am to 5:00 pm EST.
Patients who believe they have experienced any health issues potentially related to the use of this product are advised to contact their physician or healthcare provider. Adverse reactions or quality problems can also be reported to the FDA’s MedWatch Adverse Event Reporting program. Reports can be submitted online at www.fda.gov/medwatch/report.htm or by mail/fax using forms available at www.fda.gov/MedWatch/getforms.htm.
This recall is being conducted with the full knowledge of the U.S. Food and Drug Administration, underscoring the importance of vigilance in medical product safety.
Disclaimer: This article is for informational purposes only and does not constitute medical advice. Hemp Gazette does not provide medical recommendations, diagnoses, or treatment plans. Always consult a qualified healthcare practitioner before making any decisions regarding your health or any medical condition. Statements concerning the therapeutic uses of hemp, cannabis, or cannabinoid-derived products have not been evaluated by Australia’s Therapeutic Goods Administration (TGA). Medicinal cannabis products in Australia are accessed via prescription pathways under TGA regulation.
