B. Braun Medical Inc recalls 0.9% Sodium Chloride Irrigation USP, 1000 mL Plastic Irrigation Container (PIC), Rx only, B. Braun Medical Inc., Irvine…

Recall date

February 16, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0549-2018

FDA classification

Class II

Brand / firm

B. Braun Medical Inc

Sold / distributed

Nationwide in the USA

Why it was recalled

Presence of Particulate Matter: Customer complaint of particulate matter which has been identified as polyethylene, which is consistent with the material used to manufacture the container cap was received.

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

What was recalled

0.9% Sodium Chloride Irrigation USP, 1000 mL Plastic Irrigation Container (PIC), Rx only, B. Braun Medical Inc., Irvine, CA 92614, Catalog # R5200-01, NDC 0264-2201-00.