Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 5
Summary
The FDA issued a Class II for Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and fem by ICU Medical Inc.. Reason: Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic hous.
Details
Source
Device Recall
External ID
Z-2525-2025
Action Date
2025-09-10
Status
Ongoing
Category
device
Product Description
Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 50mL, Product Code 21-7301-24
Lot/Code Info: UDI/DI 10610586027215, Lot Numbers: 6005583, 6005584, 6005588, 6012462, 6022021, 6022022, 6022023, 6022024, 6022025, 6022026, 6022028, 6022030, 6022031, 6022032, 6026837, 6026839, 6037765, 6037768, 6037771, 6059294, 6059295, 6059296, 6062697, 6062698, 6077779, 6085509, 6092859, 6101810
Quantity Affected: 211750 units
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
Worldwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-08-06
Company
Minneapolis, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 258 device recalls issued in the same week, part of 413 device-related FDA actions this month.
ICU Medical Inc. has 95 FDA actions in our database, including 85 recalls and 10 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ICU Medical Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ICU Medical Inc. have FDA actions?
ICU Medical Inc. has 95 FDA actions in our database, including 85 recalls and 10 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2525-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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