FDAClass IIDecember 27, 2017

0.25% Acetic Acid Irrigation USP recall: Particulate Matter

0.25% Acetic Acid Irrigation USP, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical Inc. Irvine CA 92614-5895 USA, NDC 0264-2304-10

Why was 0.25% Acetic Acid Irrigation USP recalled?

Presence of Particulate Matter: identified as polyethylene, which is consistent with the material used to manufacture the contain cap

What should I do if I have this product?

Review the official FDA enforcement record for current 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 #: J7N965, Exp. 10/31/2020

Product
0.25% Acetic Acid Irrigation USP, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical Inc. Irvine CA 92614-5895 USA, NDC 0264-2304-10
Recalling firm
B. Braun Medical Inc
Quantity
2,576 containers
Distribution
Product was distributed nationwide.
Recall date
December 27, 2017
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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