B. Braun Medical Inc. recalls 74,088 Lactated Ringers Injection USP containers nationwide over sterility concerns. The recall cites potential fluid leakage at weld sites and lack of assurance of sterility. Healthcare providers and patients should stop use and seek guidance from their supplier or provider immediately.
Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
Consumers and healthcare providers should stop using this product immediately. Contact B BRAUN MEDICAL INC or your healthcare provider for guidance. Notification method: Letter
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Lactated Ringers Injection USP is an isotonic solution used for intravenous fluid therapy. The Excel container is a single-dose packaging format.
A sterility lapse could allow contamination. Weld-site leakage could lead to leakage of sterile fluid, increasing infection risk if used.
This recall is not part of a broader industry pattern; it highlights sterility assurance in sterile IV solutions.
Hospitals and clinics may need to quarantine affected lots and switch to alternative solutions. A recall of this scale affects facility inventories and patient care plans.
Recall notice letter and FDA enforcement listing D-0585-2025 contain identifiers.
No public timeline provided for refunds or replacements.
Keep recall notice, lot numbers, packaging photos, and correspondence with supplier.
Brand: B. Braun Medical Inc. Product: Lactated Ringer's Injection USP, L 7500, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container. NDC: 0264-7750-00. Models: J5C802, J5C917, J5C918. Quantity recalled: 74,088 containers. Distribution: Nationwide in the United States. Recall date: 2025-08-04. Status: ACTIVE.
No injuries or incidents have been reported in the recall notice.
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