Drug & medication recalls Moderate risk

B. Braun Medical Inc recalls 0.25% Acetic Acid Irrigation USP, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical Inc. Irvine CA 92614-5895…

Recall date
December 15, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0112-2018
FDA classification
Class II
Brand / firm
B. Braun Medical Inc
Sold / distributed
Product was distributed nationwide.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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