Device product
CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24JP
Z-0016-2025
Product summary
- Event
- Event 95305
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 8976 units
- Official record key
device-enforcement:Z-0016-2025
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 NA, Lot/Serial Numbers: 4013366, 4034019, 4037749, 4034021, 4040248, 4042841, 4048891, 4052407
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.