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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Home Healthcare

Smiths Medical CADD Medication Cassette Reservoirs Recalled for Leakage Risk

Agency Publication Date: September 4, 2025
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Summary

ICU Medical Inc. is recalling approximately 1,799,616 units of Smiths Medical CADD 50 mL and 100 mL Medication Cassette Reservoirs. The medication bag welds along the perimeter inside the plastic housing may be weakened, potentially causing medication to leak. This defect could lead to an under-delivery of medication or accidental exposure to the contents for patients and caregivers.

Risk

Weakened bag welds can cause medication to leak out of the reservoir during use. This may result in the patient not receiving the full prescribed dose or caregivers being accidentally exposed to the medication through contact with the leak.

What You Should Do

  1. This recall affects Smiths Medical CADD 50 mL and 100 mL Medication Cassette Reservoirs with product codes 21-7001-24, 21-7002-24, 21-7300-24, 21-7301-24, 21-7302-24, and 21-7600-24.
  2. Check the lot number and UDI/DI printed on the individual product packaging to determine if your unit is affected. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device immediately if it is part of the affected lot list.
  4. Contact ICU Medical Inc. or your medical equipment distributor to arrange for a return, replacement, or correction of the affected units.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer (50mL)
Variants: 50mL
Model / REF:
21-7001-24
Lot Numbers:
6022008
6022009
6037749
6062686
6062687
UDI:
10610586022111

Nonvented stopper included.

Product: Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer (100mL)
Variants: 100mL
Model / REF:
21-7002-24
Lot Numbers:
6022010
6026827
6026828
6026829
6026830
6026831
6037750
6037751
6037752
6037753
6053980
6053981
6053982
6053983
6062689
6062688
6063845
6062691
UDI:
10610586022128

Non-vented stopper included.

Product: Smiths Medical CADD Yellow Medication Cassette Reservoir with flow stop, clamp and female Luer (100mL)
Variants: 100mL, Yellow
Model / REF:
21-7300-24
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
UDI:
10610586027192

Non-vented stopper included.

Product: Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and female Luer (50mL)
Variants: 50mL
Model / REF:
21-7301-24
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
UDI:
10610586027215

Non-vented stopper included.

Product: Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and female Luer (100mL)
Variants: 100mL
Model / REF:
21-7302-24
Lot Numbers (85):
4468669
4468670
4468671
4468677
6004936
6005591
6005593
6005601
6012443
6012470
6012472
6012474
6012477
6022033
6022034
6022039
6022040
6022041
6022045
6022046
6022047
6022048
6022049
6022051
6022053
6026851
6026853
6026854
6026855
6026856
6026857
6026858
6026859
6026861
6026862
6026863
6026864
6026865
6026866
6026867
6026868
6026869
6026870
6026872
6026873
6026874
6026875
6037772
6037773
6037774
UDI:
10610586027239

Non-vented stopper included.

Product: Smiths Medical NRFit CADD Yellow Medication Cassette Reservoir (100mL)
Variants: 100mL, Yellow, Yellow-striped tubing, NRFit
Model / REF:
21-7600-24
Lot Numbers:
6037784
6054015
UDI:
10610586044007

With flow stop and female NRFit connector. Yellow stopper included.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97317
Status: Active
Manufacturer: ICU Medical Inc.
Sold By: Hospitals; Infusion Centers; Medical Equipment Distributors
Manufactured In: United States
Units Affected: 6 products (29811 units; 265500 units; 289098 units; 211750 units; 987911 units; 15546 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.