Recall Z-2527-2025— ICU Medical Inc.
Class II · Ongoing
Class II FDA medical device recall by ICU Medical Inc., initiated 2025-08-06. FDA's recall record names no specific 510(k) clearance for this event. 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. 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..
- Recalling firm
- ICU Medical Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-08-06
- Firm location
- Minneapolis, MN, United States
Product 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 for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.