Z-2589-2017Class II

CADD High Volume Administration Set with FlowStop, 21-7381-24

Name: Z-2589-2017 CADD High Volume Administration Set with FlowStop, 21-7381-24
Creator: Smiths Medical ASD Inc.
Published: 2017-05-15
License: https://open.fda.gov/license/

Abbott Medical / initiated 2017-05-15 / Terminated / root cause: manufacturing process

FDA source

Smiths Medical ASD Inc. began a recall of CADD High Volume Administration Set with FlowStop, 21-7381-24. Product Usage: The CADD High-Volume Administration set is designed for use with the CADD Prizm... on 2017-05-15. FDA classified it as Class II and gives the reason as "One lot of CADD High Volume Administration sets, part number 21-7381-24, lot number 26X035, incorrectly contained the IFU insert for part number 21-7357-24". 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-2589-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-15
Posted: 2018-10-11
Terminated: 2018-04-04
Recalling firm: Abbott Medical
Product: CADD High Volume Administration Set with FlowStop, 21-7381-24. Product Usage: The CADD High-Volume Administration set is designed for use with the CADD Prizm pump to allow fluid deliver from an IV bag.
Product code: FPA Set, Administration, Intravascular
Reason for recall: One lot of CADD High Volume Administration sets, part number 21-7381-24, lot number 26X035, incorrectly contained the IFU insert for part number 21-7357-24.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Consignees were sent on 5/15/2017 a Smiths Medical "Urgent Medical device Recall Notice" dated May 15, 2017. The letter described the Affected Devices, Reason for Recall, Risk to Health, & Instructions to Customers. Advised consignees to complete and send the Urgent Medical Device Recall Response Form to [email protected] within 10 calendar days of receipt of this Notice.If you have distributed affected devices to your customers, immediately notify your customers of this Recall and retrieve all affected devices. For questions contact Stericycle via email at: [email protected].
Quantity in commerce: 7,035
Distribution: US Nationwide in the states of PA, TN, NV, CA, MD, AR, CA, VA, OH, MN, NY, VT, NY.
Product codes and lots: Lot#:26X035

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2589-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2589-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-14

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)