B Braun Medical Inc: Lactated Ringer's Irrigation

Recall Summary B. Braun Medical Inc. is recalling 3000 mL bags of Lactated Ringer's Irrigation solution nationwide because the product may leak from the diaphragm port after the foil is removed, and there is no assurance the solution remains sterile. This Class II recall affects the product with NDC 0264-7389-60 distributed across all U.S. states and territories.

Recalling firm
B BRAUN MEDICAL INC
Product
LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7389-60.
Reason
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Classification
Class II
Category
drug recall
Country
United States
Agency
U.S. Food and Drug Administration
Recall date
2026-04-02
Status
Ongoing
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
US Nationwide.

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/80a12edb-3357-40f2-bfb5-b85684088060