Recall archive / FDA device enforcement
CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24 — FDA record Z-0011-2025
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 21-7302-24
- 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
- 385558 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0011-2025
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 10610586027239, Lot Numbers: 3971709, 3983317, 3983316, 3983315, 3983318, 3983327, 3983320, 3983321, 3983323, 3983328, 3983322, 4013357, 3983325, 3983324, 3983329, 3983326, 3983330, 3983332, 3983331, 3983334, 4013356, 4034028, 4013355, 4046848, 4013353, 4013358, 3983335, 4013360, 4013361, 4013359, 4013363, 4013362, 4013377, 4013374, 4013376, 4013378, 4013373, 4013375, 4034023, 4019430, 4019427, 4019428, 4034024, 4019429, 4034029, 4037751, 4034026, 4037754, 4037753, 4034031, 4034030, 4034025, 4037757, 4046846, 4037752, 4037756, 4040249, 4037755, 4042843, 4040250, 4040251, 4046845, 4042844, 4046847, 4052411, 4048893, 4066532, 4048892, 4048894, 4052410, 4053920, 4052412, 4052413, 4060911 |
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.