Z-0148-2022Class II

CADD Administration Sets, Model #21-7346-24

Name: Z-0148-2022 CADD Administration Sets, Model #21-7346-24
Creator: Smiths Medical ASD Inc.
Published: 2020-07-14
License: https://open.fda.gov/license/

Abbott Medical / initiated 2020-07-14 / Terminated / root cause: manufacturing process

FDA source

Smiths Medical ASD Inc. began a recall of CADD Administration Sets, Model #21-7346-24 on 2020-07-14. FDA classified it as Class II and gives the reason as "Product may have been manufactured with an air filter assembled in an incorrect orientation". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0148-2022
Classification: Class II
Status: Terminated
Initiated: 2020-07-14
Posted: 2021-10-19
Terminated: 2023-08-04
Recalling firm: Abbott Medical
Product: CADD Administration Sets, Model #21-7346-24
Product code: FPA Set, Administration, Intravascular
Reason for recall: Product may have been manufactured with an air filter assembled in an incorrect orientation.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm notified its consignees of the issue beginning on 07/14/2020. The firm requested the return of unused product. Distributors were directed to notify their customers. For questions contact Smiths Medical via email at [email protected].
Quantity in commerce: 371 units
Distribution: Canada
Product codes and lots: Lot Numbers: 3750848, 3776357, 3793886, 3766764, 3793887, 3796141, 3776356, 3793888, 3847669

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0148-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0148-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-27	2021-10-19

Product code FPA

K031361Class IICadd High-Volume Administration Sets with FlowstopDeltec, Inc. / cleared 2003-05-23

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)