Smiths Medical CADD Medication Cassette Reservoirs Recalled for Weakened Welds
Smiths Medical CADD medication cassette reservoirs are being recalled due to weakened welds that could allow medication to leak. Approximately 987,911 units worldwide are affected.
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 medical device recall. No illnesses or injuries have been reported. The defect presents a theoretical risk of medication leakage but no actual harm has occurred, meeting the rubric criterion for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
ICU Medical Inc. is recalling certain Smiths Medical CADD Medication Cassette Reservoirs due to weakened medication bag welds.
The recalled products are 50mL and 100mL CADD Medication Cassette Reservoirs (Product Code 21-7302-24). Certain units may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This weakness could result in medication leakage along the bag perimeter, potentially affecting drug delivery to patients.
Approximately 987,911 units have been distributed worldwide. Affected units are identified by UDI/DI number 10610586027239 and specific lot numbers including 4468669, 4468670, 4468671, and others.
Healthcare providers should check their inventory using the provided lot numbers to determine if they have affected units.
The recalled product
- Product
- Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7302-24
- 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 10610586027239
- Lot Numbers: 4468669
- 4468670
- 4468671
- 4468677
- 6004936
- 6005591
- 6005593
- 6005601
- 6012443
- 6012470
- 6012472
- 6012474
- 6012477
- 6022033
- 6022034
- 6022039
- 6022040
- 6022041
- 6022045
Distribution
Distribution scope not specified by the agency.
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