Two companies are recalling different lots of 0.9% Sodium Chloride Injection products after concerns that particulate matter could be present in solutions intended for intravenous use.
B. Braun Medical Inc. announced a nationwide recall involving three lots of its 0.9% Sodium Chloride Injection USP, 100 mL, while Baxter International Inc. recalled two lots of its 500 mL Sodium Chloride Injection, USP. Both recalls involve products distributed to hospitals and other health care facilities.
The U.S. Food and Drug Administration published the B. Braun recall on August 28 and the Baxter recall on August 26.
B. Braun Recall Involves Zinc Oxide
B. Braun is recalling three lots of 0.9% Sodium Chloride Injection USP, 100 mL, packaged in a 150 mL PAB container because of particulate matter identified as zinc oxide.
The recalled products were distributed nationwide to hospitals and health care facilities between February 27 and August 3, 2026.
The affected products are:
- Catalog number: S8004-5264
- NDC number: 0264-1800-32
- Lot J6B435, expiration April 30, 2027
- Lot J6B444, expiration April 30, 2027
- Lot J6B457, expiration April 30, 2027
B. Braun said intravenous administration of a product containing particulate matter could potentially cause serious or life-threatening complications, including pulmonary embolism, blockage of other blood vessels, phlebitis, immune-system activation, organ dysfunction, and hemolysis.
The company said it has not received reports of serious injuries, deaths or other adverse events associated with the issue.
B. Braun is notifying distributors and customers and arranging for recalled products to be returned and replaced. Facilities with affected products should return them to their place of purchase.
Baxter Recall Involves Fiberglass
Baxter is separately recalling two lots of 0.9% Sodium Chloride Injection, USP, 500 mL VIAFLEX Plastic Containers because of the potential presence of fiberglass particulate matter.
The affected products were distributed from July 31 through Aug. 3, 2026, to health care providers and distributors in 14 states, including Texas, Florida, Illinois, Indiana, Louisiana, Maryland, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, South Carolina, and Virginia.
The recalled products are:
- Product code: 2B1323Q
- NDC number: 0338-0049-03
- Lot Y495523, expiration Oct. 31, 2027
- Lot Y495523A, expiration Oct. 31, 2027
Baxter said particulate matter introduced intravenously can cause blood-vessel blockage and clotting, potentially resulting in pulmonary embolism, permanent organ damage, or death. Other potential complications include vein irritation, inflammatory reactions, worsening of existing infections and allergic reactions.
As of August 25, Baxter said it had not received reports of adverse events associated with the recalled products.
Customers should immediately discontinue use of affected units and follow Baxter’s instructions for returning them.
What Facilities Should Do
Both recalls concern products administered intravenously, making identification of affected lots particularly important for hospitals and other health care facilities.
Facilities should check product packaging and shipping cartons for the applicable product and lot numbers and follow the respective manufacturers’ instructions for returning affected inventory.
Patients or consumers who believe they experienced a problem associated with either product should contact a health care provider. Adverse reactions and product-quality concerns can also be reported through the FDA’s MedWatch program.
For questions about the B. Braun recall, contact B. Braun at recalls@bbraunusa.com, Monday through Friday from 8 a.m. to 5 p.m. Eastern time.
For questions about the Baxter recall, contact the Baxter Healthcare Center for Service at 888-229-0001, Monday through Friday from 7 a.m. to 6 p.m. Central Time.
Provided by Dallas Express
