Nationwide Recall Issued for B. Braun Saline Bags Over Particulate Contamination
iSkyNews.com
BETHLEHEM, Pa. — B. Braun Medical Inc. is recalling three lots of a commonly used sodium chloride injection after particulate matter was found in the product.
The recall involves 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® container. According to a company announcement published by the U.S. Food and Drug Administration on September 3, 2026, the particles were identified as iron oxide, inorganic material, cellulose or polystyrene.
The product was distributed nationwide to hospitals and healthcare facilities between February 27 and August 3, 2026.
B. Braun says the concern is that if particulate matter is infused into a patient, it could cause serious complications, including blood vessel blockages, pulmonary emboli, inflammation of the veins, organ damage, immune system reactions and the breakdown of blood cells.
The company says no serious injuries, deaths or other adverse events have been reported to date in connection with the recall.
The saline solution is used in both adults and children for hydration and as a source of electrolytes. It can also be used to dilute and deliver compatible medications through an IV.
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| B. Braun Medical Inc. is recalling three lots of its 0.9% Sodium Chloride Injection USP after particulate matter, including iron oxide and other contaminants, was identified in the product. The recalled saline was distributed nationwide to hospitals and healthcare facilities. Source: FDA / B. Braun Medical Inc. |
The affected product has catalog number S8004-5264 and NDC number 0264-1800-32. The recalled lot numbers are J6B435, J6B444 and J6B457, all with an expiration date of April 30, 2027.
B. Braun says it is contacting distributors and healthcare customers and arranging for the affected products to be returned and replaced.
Anyone who has questions about the recall can contact B. Braun at recalls@bbraunusa.com Monday through Friday from 8 a.m. to 5 p.m. Eastern Time.
Company Contact Information
- Consumers:
- B. Braun
- recalls@bbraunusa.com
- Media:
- Allison Longenhagen
- allison.longenhagen@bbraunusa.com
People who believe they may have experienced a problem related to the recalled product should contact their healthcare provider. Adverse reactions and product quality issues can also be reported through the FDA’s MedWatch program.
The recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Source: U.S. Food and Drug Administration / B. Braun Medical Inc.
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