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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 ASD Inc.: CADD Medication Reservoirs Recalled Due to Potential Medication Leakage

Agency Publication Date: October 18, 2024
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Summary

Smiths Medical ASD Inc. has recalled over 3.8 million CADD Medication Cassette Reservoirs and ENT Reservoirs because of a production equipment malfunction. This defect caused a weakened weld joint where the medication bag meets the tubing, which can lead to medication leaking out of the system. These products are used for delivering medication and fluids to patients. Consumers should identify if their specific lot number is affected and contact their healthcare provider or the manufacturer for guidance on receiving a potential refund or replacement.

Risk

A weakened joint between the medication bag and the tubing can cause the medication to leak. This may result in the patient receiving an incorrect dose of medication or being exposed to potential infection if the fluid path is compromised.

What You Should Do

  1. Check the product label for the Product Code and Lot Number to see if your device is affected. Affected Product Codes include 21-7002-24, 21-7302-24, 21-7300-24, 21-7301-24, 21-7001-24, 21-7302-24JP, 21-7301-24JP, 68-2230-28, and 68-2231-28.
  2. If your product matches one of the affected lot numbers, such as 3977441, 4013370, or any of the hundreds of specific codes listed in the recall documentation, contact your healthcare provider immediately.
  3. Inspect any unused CADD Medication Cassette Reservoirs for signs of leakage or moisture near the tubing connection point before use.
  4. Contact Smiths Medical ASD Inc. at their Minneapolis office or via their official support channels for instructions on how to handle affected units and to inquire about replacements or refunds.
  5. Report any adverse events or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program.
  6. For additional questions or help identifying your product, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Contact healthcare provider or manufacturer

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: CADD Medication Cassette Reservoir (100mL)
Model / REF:
21-7002-24
UPC Codes:
1061058602228
Lot Numbers:
3977441
4013370
3983314
4013371
4013369
4013372
4025948
4033993
4037444
4040238
Product: CADD Medication Cassette Reservoir, FS (100mL)
Model / REF:
21-7302-24
UPC Codes:
10610586027239
Lot Numbers (74):
3971709
3983317
3983316
3983315
3983318
3983327
3983320
3983321
3983323
3983328
3983322
4013357
3983325
3983324
3983329
3983326
3983330
3983332
3983331
3983334
4013356
4034028
4013355
4046848
4013353
4013358
3983335
4013360
4013361
4013359
4013363
4013362
4013377
4013374
4013376
4013378
4013373
4013375
4034023
4019430
4019427
4019428
4034024
4019429
4034029
4037751
4034026
4037754
4037753
4034031
Product: CADD Medication Cassette Reservoir, FS, YELLOW (100mL)
Model / REF:
21-7300-24
UPC Codes:
10610586027192
Lot Numbers:
3971732
3971731
4034016
3977457
4013365
4019421
4019422
4034015
4037744
4037745
4034018
4034017
4046844
4046843
4053912
4048899
Product: CADD Medication Cassette Reservoir, FS (50mL)
Model / REF:
21-7301-24
UPC Codes:
10610586027215
Lot Numbers:
4042839
4040248
4034021
4052405
4034022
4037748
4042841
4034019
4037749
4040247
3983339
3983338
3983340
4013367
4013366
3988532-ENG
3983337
4052406
4042840
4052407
4052408
4042842
4048891
4052409
Product: CADD Medication Cassette Reservoir (50mL)
Model / REF:
21-7001-24
UPC Codes:
10610586022111
Lot Numbers:
4040237
4013368
3983342
4046817
405240
4060903
Product: CADD Medication Cassette Reservoir, FS, JP (100mL)
Model / REF:
21-7302-24JP
Lot Numbers:
3983315
3971709
3983316
3983320
3983329
4013361
4013363
4013373
4013377
4013378
4019427
4019429
4034028
4037753
4052410
4040250
4042843
4048894
4046846
4052412
4052413
Product: CADD Medication Cassette Reservoir, FS, JP (50mL)
Model / REF:
21-7301-24JP
Lot Numbers:
4013366
4034019
4037749
4034021
4040248
4042841
4048891
4052407
Product: ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER
Model / REF:
68-2230-28
UPC Codes:
30610586044179
Lot Numbers (203):
4010559AB
4010560AB
4010563AB
4010573AB
4016496AB
4010561AB
4010562AB
4016490AB
4010570AB
4010569AB
4016494AB
4016497AB
4010571AB
4016491AB
4010572AB
4010574AB
4016493AB
4022630AB
4025275AB
4016492AB
4016495AB
4022621AB
4022625AB
4022628AB
4006931AB
4006933AB
4006930AB
4006932AB
4022622AB
4022623AB
4022627AB
4022624AB
4022626AB
4022632AB
4022629AB
4022631AB
4025277AB
4022633AB
4022634AB
4025274AB
4022635AB
4033938AB
4033939AB
4025281AB
4033937AB
4025278AB
4025279AB
4025280AB
4033943AB
4025288AB
Product: ENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER
Model / REF:
68-2231-28
UPC Codes:
30610586044186
Lot Numbers:
3997242-ENG
4040002AB
4040000AB
4040001AB
4040008AB
4040007AB
4040009AB
4146021AB

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95305
Status: Active
Manufacturer: Smiths Medical ASD Inc.
Sold By: Authorized Medical Distributors; Hospitals; Clinics
Manufactured In: United States
Units Affected: 9 products (125928 units; 385558 units; 26160 units; 119535 units; 41964 units; 109563 units; 8976 units; 2881080 units; 120960 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.

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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.