Recall archive / FDA device enforcement
CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24JP — FDA record Z-0015-2025
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, 100mL, FS, Product Code 21-7302-24JP
- 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
- 109563 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0015-2025
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 | UID/DI NA, Lot/Serial Numbers: 3983315, 3971709, 3983316, 3983320, 3983329, 4013361, 4013363, 4013373, 4013377, 4013378, 4019427, 4019429, 4034028, 4037753, 4052410, 4040250, 4042843, 4048894, 4046846, 4052412, 4052413 |
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.