Smiths Medical CADD" Yellow Medication Cassette Reservoir with flow stop, clamp and female Luer. ...
FDA Recall #Z-2524-2025 — Class II — August 6, 2025
Product Description
Smiths Medical CADD" Yellow Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included 100mL, Product Code 21-7300-24
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.
Recalling Firm
ICU Medical Inc. — Minneapolis, MN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
289098 units
Distribution
Worldwide distribution.
Code Information
UDI/DI 10610586027192, Lot Numbers: 6012453, 6022016, 6022019, 6026832, 6026833, 6026834, 6026835, 6026836, 6037755, 6037756, 6037757, 6037758, 6037759, 6037760, 6053986, 6053987, 6053988, 6053990, 6053989, 6053985, 6062696, 6062694, 6062695
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated