Device product
CADD Medication Cassette Reservoir, 50mL, Product Code 21-7001-24
Z-0014-2025
Product summary
- Event
- Event 95305
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 41964 units
- Official record key
device-enforcement:Z-0014-2025
Official wording
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.
Code information: UDI/DI 10610586022111, Lot Numbers: 4040237, 4013368, 3983342, 4046817, 405240, 4060903
Distribution pattern: Worldwide distribution.
Derived failure modes
-
Unknown
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.