CADD Medication Cassette Reservoirs recalled for potential medication leakage
ICU Medical is recalling approximately 265,500 CADD 50mL and 100mL Medication Cassette Reservoirs worldwide due to weakened bag welds that could cause medication leakage during use.
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 Class II medical device recall involves a risk-of-harm product (medication infusion cassette) where potential medication leakage could compromise critical drug delivery. No illnesses or injuries have been reported.
Plain-English summary
ICU Medical Inc. is recalling certain CADD 50mL and 100mL Medication Cassette Reservoirs (Product Code 21-7002-24, UDI/DI 10610586022128) due to a manufacturing defect in the medication bag assembly.
The recalled medication cassettes may have weakened welds along the bag perimeter inside the plastic housing. This defect could result in medication leakage from the bag, potentially compromising the accurate delivery of infusion medications to patients.
Approximately 265,500 units have been distributed worldwide. The affected lot numbers are: 6022010, 6026827, 6026828, 6026829, 6026830, 6026831, 6037750, 6037751, 6037752, 6037753, 6053980, 6053981, 6053982, 6053983, 6062689, 6062688, 6063845, and 6062691.
Healthcare providers and patients using affected cassettes should discontinue use immediately and contact ICU Medical for replacement instructions or to report any adverse events.
The recalled product
- Product
- Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7002-24
- 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 (19)
- UDI/DI 10610586022128
- Lot Numbers: 6022010
- 6026827
- 6026828
- 6026829
- 6026830
- 6026831
- 6037750
- 6037751
- 6037752
- 6037753
- 6053980
- 6053981
- 6053982
- 6053983
- 6062689
- 6062688
- 6063845
- 6062691
Distribution
Distribution scope not specified by the agency.
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