FDAFDA · Food and drugs·Recall number Z-0012-2025
CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Published October 30, 2024 · Recall initiated: June 26, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Smiths Medical ASD Inc.
- Distributor
- Worldwide distribution.
- Lot
- UDI/DI 10610586027192, Lot Numbers: 3971732, 3971731, 4034016, 3977457, 4013365, 4019421, 4019422, 4034015, 4037744, 4037745, 4034018, 4034017, 4046844, 4046843, 4053912, 4048899
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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