FDA Medical devices recall ·
Smiths Medical NRFit CADD Yellow Medication Cassette Reservoir with NRFit… recall
- Recall number
- Z-2527-2025
- Date
- (initiated August 6, 2025)
- Company / brand
- ICU Medical, Inc.
6000 Nathan Ln N, Minneapolis, MN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 15546 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI/DI 10610586044007, Lot Numbers: 6037784, 6054015
Distribution
Worldwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2527-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.