FDA Enforcement
Class II
Ongoing
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
Recall: Z-2527-2025
·
Reported September 10, 2025
Enforcement
- Recall Number
- Z-2527-2025
- Event ID
- 97317
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- ICU Medical Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- September 10, 2025
- Initiation Date
- August 6, 2025
- Classification Date
- September 4, 2025
- Address
- 6000 Nathan Ln N, N/A, Minneapolis, MN, 55442-1690, United States
Description
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
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 Info
UDI/DI 10610586044007, Lot Numbers: 6037784, 6054015
Distribution
Worldwide distribution.
Quantity
15546 units