FDA-Drug2025-08-20Class II

Lactated Ringer's Injection USP, L 7500, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00.

B BRAUN MEDICAL INC
Hazard

Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.

Sold states
Nationwide in the US
Affected count
74,088 containers
Manufactured in
861 Marcon Blvd, N/A, Allentown, PA, United States
Products
Lactated Ringer's Injection USP, L 7500, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0585-2025

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