Z-0012-2025Class II

CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24

Name: Z-0012-2025 CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Creator: Smiths Medical ASD Inc.
Published: 2024-06-26
License: https://open.fda.gov/license/

Abbott Medical / initiated 2024-06-26 / Open, Classified / root cause: manufacturing process

FDA source

Smiths Medical ASD Inc. began a recall of CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24 on 2024-06-26. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0012-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-06-26
Posted: 2024-10-18
Recalling firm: Abbott Medical
Product: CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Product code: FPA Set, Administration, Intravascular
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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]
Quantity in commerce: 26160 units
Distribution: Worldwide distribution.
Product codes and lots: UDI/DI 10610586027192, Lot Numbers: 3971732, 3971731, 4034016, 3977457, 4013365, 4019421, 4019422, 4034015, 4037744, 4037745, 4034018, 4034017, 4046844, 4046843, 4053912, 4048899

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0012-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0010-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-18
Z-0011-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-18
Z-0012-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-18
Z-0013-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-18
Z-0014-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-18
Z-0015-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-18
Z-0016-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-18
Z-0017-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-18
Z-0018-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-18

Product code FPA

K081156Class IICadd Medication Cassette ReservoirSmiths Medical MD, Inc. / cleared 2008-07-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)