Z-2522-2025 Class II Ongoing
FDA device recall Z-2522-2025 was initiated by ICU Medical Inc. on August 6, 2025 and is designated Class II. Reason for recall: Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage alon… The recall status is ongoing. Affected quantity: 29811 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 10, 2025
- Initiation Date
- August 6, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 29811 units
Product Description
Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included. 50mL, Product Code 21-7001-24
Reason for Recall
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
Distribution Pattern
Worldwide distribution.
Code Information
UDI/DI 10610586022111, Lot Numbers: 6022008, 6022009, 6037749, 6062686, 6062687