Device 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
Z-2527-2025
Product summary
- Firm
- ICU Medical Inc.
- Event
- Event 97317
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 15546 units
- Official record key
device-enforcement:Z-2527-2025
Official wording
Reason: 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.
Code information: UDI/DI 10610586044007, Lot Numbers: 6037784, 6054015
Distribution pattern: Worldwide distribution.
Derived failure modes
-
Unknown
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.