FDAFDA · Food and drugs·Recall number Z-0013-2025
CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24
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 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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