Smiths Medical CADD Cassette Reservoirs Recalled for Potential Medication Leakage
Smiths Medical CADD medication cassette reservoirs may leak due to weakened bag welds. The recall involves 15,546 units distributed worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall without reported illnesses, injuries, or hospitalizations. The hazard is a risk-of-harm product (potential medication leakage) where injury has not yet been reported, meeting the rubric criterion for High severity.
Plain-English summary
Smiths Medical NRFit CADD Yellow Medication Cassette Reservoirs (100 mL, Product Code 21-7600-24) manufactured by ICU Medical Inc. are being recalled due to potential medication leakage.
Certain units may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This defect could result in medication leakage along the bag perimeter.
The recall affects 15,546 units distributed worldwide. Affected lot numbers are 6037784 and 6054015 (UDI/DI 10610586044007).
Patients and healthcare facilities with these cassette reservoirs should verify the lot number and contact the manufacturer or their healthcare provider with any concerns about affected units.
The recalled product
- 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
- Manufacturer
- ICU Medical Inc.
- Hazard
- medication-leakage
- weakened-weld
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI/DI 10610586044007
- Lot Numbers: 6037784
- 6054015
Distribution
Distribution scope not specified by the agency.
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