Medical device recalls Moderate risk

ICU Medical Inc. recalls Smiths Medical NRFit CADD Yellow Medication Cassette Reservoir with NRFit connector with flow stop, yellow-striped tubi…

Recall date
August 6, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2527-2025
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 NRFit CADD Yellow Medication Cassette Reservoir with NRFit connector with flow stop, yellow-striped tubing, clamp and female NRFit connector. Yellow stopper included 100mL", Product Code 21-7600-24

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