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Recall Observatory FDA recall evidence

Device product

Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7002-24

Z-2523-2025

August 06, 2025

Class II

Product summary

Firm
ICU Medical Inc.
Event
Event 97317
Status
Ongoing
Classification
Class II
Quantity
265500 units
Official record key
device-enforcement:Z-2523-2025

Official wording

Reason: 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.

Code information: UDI/DI 10610586022128, Lot Numbers: 6022010, 6026827, 6026828, 6026829, 6026830, 6026831, 6037750, 6037751, 6037752, 6037753, 6053980, 6053981, 6053982, 6053983, 6062689, 6062688, 6063845, 6062691

Distribution pattern: Worldwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.