CADD Medication Cassette Reservoir Recalled for Potential Medication Leakage
ICU Medical is recalling certain CADD medication cassette reservoirs worldwide due to weakened bag welds that could allow medication to leak. No illnesses have been reported.
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 a risk-of-harm medical device where injury has not yet been reported. The source explicitly states no illnesses or injuries and describes a theoretical hazard (potential medication leakage). Per the rubric, risk-of-harm products without reported injury are rated Severity 3.
Plain-English summary
ICU Medical Inc. is recalling certain Smiths Medical CADD 50 mL Medication Cassette Reservoirs with lot numbers 6022008, 6022009, 6037749, 6062686, and 6062687. These devices are used as part of medication infusion systems to hold and deliver medications to patients.
Certain affected units may have weakened welds along the bag perimeter inside the plastic housing. This defect could result in medication leaking from the cassette reservoir during use.
Approximately 29,811 units have been distributed worldwide. Healthcare facilities and patients using cassette reservoirs with the identified lot numbers may be affected.
Users should stop using affected units and contact their healthcare provider or ICU Medical for replacement or further instructions.
The recalled product
- Product
- Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included. 50mL, Product Code 21-7001-24
- Manufacturer
- ICU Medical Inc.
- Hazard
- medication-leakage
- device-defect
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 (6)
- UDI/DI 10610586022111
- Lot Numbers: 6022008
- 6022009
- 6037749
- 6062686
- 6062687
Distribution
Distribution scope not specified by the agency.
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