FDAHealthAugust 6, 2025
ICU Medical Inc. — Smiths Medical CADD" Yellow Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included 100mL, Product Code 21-7300-24
⚠️ 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" Yellow Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included 100mL, Product Code 21-7300-24
- Brand
- ICU Medical Inc.
- Lot code
- 6012453
Additional details
UDI/DI 10610586027192, Lot Numbers: 6012453, 6022016, 6022019, 6026832, 6026833, 6026834, 6026835, 6026836, 6037755, 6037756, 6037757, 6037758, 6037759, 6037760, 6053986, 6053987, 6053988, 6053990, 6053989, 6053985, 6062696, 6062694, 6062695
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 289098 units.
Get Health recall alerts
Delivered to your inbox. Free. No account required.