FDAHealthAugust 6, 2025
ICU Medical Inc. — 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
⚠️ 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.
Is this relevant to me?
- Geography
- Unknown
- Source agency
- FDA
- Category
- Health
- Published
- August 6, 2025
Worldwide distribution.
What's affected?
- Product
- 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
- Brand
- ICU Medical Inc.
- Lot code
- 6037784
Additional details
UDI/DI 10610586044007, Lot Numbers: 6037784, 6054015
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 15546 units.
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