CADD recallZ-0013-2025 · Smiths Medical ASD Inc. · initiated Jun 26, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Smiths Medical ASD Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.
FDA root cause category: Process control
What the company is doing
Smiths Medical issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 06/26/2024 via mail. The notice explained the issue, potential risks, and requested the affected product be quarantined, and the response for returned to initiate the return and replacement process. Distributors were directed to notify their customers. For further inquires: Product complaints or adverse events: [email protected] 1-(866)-216-8806 Additional information or technical assistance 1-(800)-241-4002, option 3 [email protected]
Recall details
- Recall number
- Z-0013-2025
- Status
- Open, Classified
- Initiated by the company
- Jun 26, 2024
- Posted by the FDA
- Oct 18, 2024
- Recalling firm
- Smiths Medical ASD Inc.
- Quantity
- 119535 units
- Product code
- FPA
- FDA submissions
- K081156
- Distribution
- Worldwide distribution.
Product description
CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24
Code information (models, lots, serial numbers)
UDI/DI 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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- CADD 21-7301-24Icu Medical, Inc. · Set, administration, intravascular4 recalls467 reports
Product lines
Other devices under the same FDA submission
3 devices cleared under K081156 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- CADD 21-7308-24Icu Medical, Inc. · Set, administration, intravascular2 recalls1 death526 reports
- CADD 21-7309-24Icu Medical, Inc. · Set, administration, intravascular2 recalls80 reports
- CADD 21-7310-24Icu Medical, Inc. · Set, administration, intravascular2 recalls21 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 95305).
- Z-0010-2025 · Open, ClassifiedCADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
- Z-0011-2025 · Open, ClassifiedCADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
- Z-0012-2025 · Open, ClassifiedCADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
- Z-0014-2025 · Open, ClassifiedCADD Medication Cassette Reservoir, 50mL, Product Code 21-7001-24
- Z-0015-2025 · Open, ClassifiedCADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24JP
- Z-0016-2025 · Open, ClassifiedCADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24JP
- Z-0017-2025 · Open, ClassifiedENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product Code 68-2230-28
- Z-0018-2025 · Open, ClassifiedENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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