ICU Medical Inc. recalls Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included.…

Recall date

August 6, 2025

Source

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

Recall number

Z-2525-2025

FDA classification

Class II

Brand / firm

ICU Medical Inc.

Sold / distributed

Worldwide distribution.

Why it was recalled

Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.

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

What was recalled

Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 50mL, Product Code 21-7301-24