CADD Medication Cassette Reservoir Recall Due to Weakened Welds
ICU Medical is recalling certain CADD Medication Cassette Reservoirs due to weakened bag welds that may cause medication leakage. No injuries 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 Class II recall for a risk-of-harm medical device where medication leakage could compromise drug delivery. However, no injuries or illnesses have been reported, and the hazard is theoretical rather than confirmed.
Plain-English summary
ICU Medical Inc. is recalling certain CADD Medication Cassette Reservoirs (50mL and 100mL models), Product Code 21-7301-24. Approximately 211,750 units are affected and have been distributed worldwide.
The recalled devices 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, which could potentially compromise proper medication delivery.
The FDA classified this as a Class II recall. No illnesses or injuries have been reported in connection with this defect.
The recalled product
- Product
- Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 50mL, Product Code 21-7301-24
- Manufacturer
- ICU Medical Inc.
- Hazard
- medication-leakage
- weld-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 (20)
- UDI/DI 10610586027215
- Lot Numbers: 6005583
- 6005584
- 6005588
- 6012462
- 6022021
- 6022022
- 6022023
- 6022024
- 6022025
- 6022026
- 6022028
- 6022030
- 6022031
- 6022032
- 6026837
- 6026839
- 6037765
- 6037768
- 6037771
Distribution
Distribution scope not specified by the agency.
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