Lactated Ringers Irrigation 3000 mL Bags Recall: Sterility Concern
B. Braun Medical Inc. is recalling Lactated Ringers Irrigation 3000 mL bags due to lack of assurance of sterility and potential leakage from the diaphragm port after foil removal.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazards identified (lack of sterility assurance and potential leakage) are serious quality/contamination risks that warrant action, but without evidence of actual harm, this meets the criteria for Moderate severity.
Plain-English summary
B. Braun Medical Inc. is recalling specific lots of Lactated Ringers Irrigation 3000 mL bags (NDC: 0264-7389-60) distributed nationwide. The recall affects 54,540 bags and involves lot numbers J5E234, J5E236, J5H158, J5H159, J5H160, J5H161, J5H162, J5H163, J5H174, and J5H175.
The product is being recalled due to a lack of assurance of sterility and potential for leakage from the diaphragm port once the foil is removed. Lactated Ringers Irrigation is a sterile medical irrigation solution used in healthcare settings.
Affected lot numbers with expiration date 30APR2028 are J5E234 and J5E236. Affected lot numbers with expiration date 31MAY2028 are J5H158, J5H159, J5H160, J5H161, J5H162, J5H163, J5H174, and J5H175. Healthcare providers and facilities with affected product should cease use and contact B. Braun Medical Inc. for return or disposal instructions.
The recalled product
- Product
- LACTATED RINGERS IRRIGATION (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE AND CALCIUM CHLORIDE)
- Brand
- LACTATED RINGERS IRRIGATION
- Manufacturer
- B BRAUN MEDICAL INC
- Category
- Drug — Irrigation Solution
- Hazard
- sterility-assurance
- leakage-risk
- contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- Lot # J5E234
- J5E236
- Exp Date: 30APR2028
- Lot # J5H158
- J5H159
- J5H160
- J5H161
- J5H162
- J5H163
- J5H174
- J5H175
- Exp Date: 31MAY2028.
Distribution
Distributed nationwide across the United States.