FDAHealthAugust 6, 2025
ICU Medical Inc. — Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included. 50mL, Product Code 21-7001-24
⚠️ 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 CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included. 50mL, Product Code 21-7001-24
- Brand
- ICU Medical Inc.
- Lot code
- 6022008
Additional details
UDI/DI 10610586022111, Lot Numbers: 6022008, 6022009, 6037749, 6062686, 6062687
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 29811 units.
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