COMPANY ANNOUNCEMENT
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
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- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Drugs
- Reason for Announcement:
-
Recall Reason Description
Due to the presence of particulate matter.
- Company Name:
- B. Braun Medical, Inc.
- Brand Name:
- Product Description:
-
Product Description
Lactated Ringer’s Injection USP 1000 mL/0.9% Sodium Chloride Injection USP 1000 mL
Company Announcement
For Immediate Release - BETHLEHEM, PA – August 19, 2025 – B. Braun Medical Inc. (B. Braun) is voluntarily recalling two lots of Lactated Ringers Injection USP 1000 mL, and 0.9% Sodium Chloride Injection USP 1000 mL to the hospital level due to the presence of particulate matter inside the container.
B. Braun has identified through complaints the potential for the product to contain particulate matter in solution. To date there have been no reports of serious injury, death or other adverse events associated with this issue. If the particulate matter is observed before use, a minor delay could occur while obtaining a replacement product. If the particulate matter is loose and the container is used on a patient, there is a potential for the particulate to be infused into the circulatory system. This could lead to patient harm that may require additional medical intervention and/or lead to permanent impairment or death.
The 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 there have been no reports of serious injury, death or other adverse events associated with this issue.
The product is used as a state indication(s) and is packaged in state type of packaging, number of units, and any associated codes. The affected products are as follows:
Product |
NDC Number |
Product Description |
Lot |
Distribution |
Expiration |
Region |
|---|---|---|---|---|---|---|
E7500 |
0264-7750-07 |
Lactated Ringers Injection |
J4S807 |
26DEC2024 |
31MAY2027 |
US |
E8000 |
0264-7800-09 |
0.9% Sodium Chloride |
V3K770 |
15NOV2023 |
31JAN2026 |
US |
Product was distributed [Worldwide/Nationwide] to describe type of outlets (wholesale/retail/via internet).
B. Braun is notifying its distributors and customers by certified mail and is arranging for return. of all recalled products. Distributors that have affected product which is being recalled should determine their current inventory of the affected items within inventory of their facility, cease use and distribution and quarantine product subject to recall. Affected product should not be destroyed.
Customers who have questions about this recall should contact our B. Braun’s Recalls Department at 844-903-6417 between 9 AM and 5 PM 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.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
About B. Braun
B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pennsylvania and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap® and CAPS®.
Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise® philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, explore our website.
