Smiths Medical CADD Medication Cassette Reservoirs Recalled for Potential Medication Leakage
ICU Medical is recalling Smiths Medical CADD 100mL medication cassette reservoirs due to weakened bag welds that may cause medication leakage. The recall involves 289,098 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: FDA Class II medical device recall presenting a risk-of-harm through potential medication leakage from infusion cassettes. No illnesses or injuries have been reported in the source, placing this in the High severity category per rubric criteria for risk-of-harm products without documented injury.
Plain-English summary
ICU Medical Inc. is recalling Smiths Medical CADD 100mL Yellow Medication Cassette Reservoirs (Product Code 21-7300-24, UDI/DI 10610586027192) due to a manufacturing defect affecting medication bag welds. The recall involves 289,098 units distributed worldwide.
Certain cassettes may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This weakening could result in medication leakage along the bag perimeter during use.
The affected lot numbers are: 6012453, 6022016, 6022019, 6026832, 6026833, 6026834, 6026835, 6026836, 6037755, 6037756, 6037757, 6037758, 6037759, 6037760, 6053985, 6053986, 6053987, 6053988, 6053989, 6053990, 6062694, 6062695, and 6062696.
As of this recall notice, no illnesses or injuries have been reported.
The recalled product
- Product
- Smiths Medical CADD" Yellow Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included 100mL, Product Code 21-7300-24
- Manufacturer
- ICU Medical Inc.
- Category
- Medical Device — Infusion Device
- Hazard
- medication-leakage
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 (20)
- UDI/DI 10610586027192
- Lot Numbers: 6012453
- 6022016
- 6022019
- 6026832
- 6026833
- 6026834
- 6026835
- 6026836
- 6037755
- 6037756
- 6037757
- 6037758
- 6037759
- 6037760
- 6053986
- 6053987
- 6053988
- 6053990
- 6053989
Distribution
Distribution scope not specified by the agency.
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