FDAClass IIApril 29, 2026

Lactated Ringer's Irrigation recall: Sterility Concern

LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7389-60.

Why was Lactated Ringer's Irrigation recalled?

Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # J5E234, J5E236, Exp Date: 30APR2028; Lot # J5H158, J5H159, J5H160, J5H161, J5H162, J5H163, J5H174, J5H175, Exp Date: 31MAY2028.

Product
LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7389-60.
Recalling firm
B BRAUN MEDICAL INC
Quantity
54,540 bags
Distribution
US Nationwide.
Recall date
April 29, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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