Recall archive / FDA device enforcement
CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24 — FDA record Z-0013-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jun 26, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24
- Reason
- Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.
- Classification
- Class II
- Recalling firm
- Smiths Medical ASD Inc.
- Quantity
- 119535 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0013-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI/DI 10610586027215, Lot Numbers: 4042839, 4040248, 4034021, 4052405, 4034022, 4037748, 4042841, 4034019, 4037749, 4040247, 3983339, 3983338, 3983340, 4013367, 4013366, 3988532-ENG, 3983337, 4052406, 4042840, 4052407, 4052408, 4042842, 4048891, 4052409 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Oct 30, 2024
- Recall initiation date
- Jun 26, 2024
- Center classification date
- Oct 18, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.