Z-1831-2016Class II

CADD Administration Sets with Flow Stop, Product Reorder No: 21-7321-01, 21-7321-24, 21-7322-01, 21-7322-24...

Name: Z-1831-2016 CADD Administration Sets with Flow Stop, Product Reorder No: 21-7321-01, 21-7321-24, 21-7322-01, 21-7322-24...
Creator: Smiths Medical ASD, Inc.
Published: 2016-04-22
License: https://open.fda.gov/license/

Abbott Medical / initiated 2016-04-22 / Terminated / root cause: manufacturing process

FDA source

Smiths Medical ASD, Inc. began a recall of CADD Administration Sets with Flow Stop, Product Reorder No: 21-7321-01, 21-7321-24, 21-7322-01, 21-7322-24, 21-7323-24, 21-7324-01, 21-7324-24, 21-7333-24... on 2016-04-22. FDA classified it as Class II and gives the reason as "Smiths Medical became aware that under delivery of medication may occur on CADD Administration Sets with Flow Stop". 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-1831-2016
Classification: Class II
Status: Terminated
Initiated: 2016-04-22
Posted: 2016-05-27
Terminated: 2017-12-13
Recalling firm: Abbott Medical
Product: CADD Administration Sets with Flow Stop, Product Reorder No: 21-7321-01, 21-7321-24, 21-7322-01, 21-7322-24, 21-7323-24, 21-7324-01, 21-7324-24, 21-7333-24, 21-7336-01, 21-7336-24, 21-7339-01, 21-7339-24, 21-7359-01, 21-7359-24, 21-7383-01, 21-7383-24, 21-7390-01, 21-7390-24, 21-7391-01, 21-7391-24, 21-7394-01, 21-7394-24, 21-7395-24. The CADD Medication Cassette Reservoirs with Flow Stop are a modification to the current CADD Medication Cassette Reservoirs. The reservoirs will incorporate a set-based free flow protection component (i.e. Flow Stop) that is designed to occlude the tube if the reservoirs are accidentally placed onto the pump incorrectly or become detached from the pump. The Flow Stop will be located on the reservoir housing, which is attached to the pump. The reservoir will be provided to the user in an open state. Before the reservoir can be attached to the pump, the blue "CLIP" must be removed to activate the Flow Stop. However, after attaching the reservoir to the pump, the user can still remove the reservoir from the pump and prime it by holding the Flow Stop in the open position.
Product code: FPA Set, Administration, Intravascular
Reason for recall: Smiths Medical became aware that under delivery of medication may occur on CADD Administration Sets with Flow Stop.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Smiths Medical sent an "Urgent Medical Device Field Correction Action" letter dated April 20, 2016. The letter was addressed to "Clinicians who oversee the use of the CADD Administration Sets with Flow Stop and Distributors thereof". The letter described the Affected devices, Reason for Field Correction Action, Risk to Health, and Instructions to Customers (Distributors and Clinicians). Requested consignees to complete and return the "Field Corrective Action Confirmation Form". For questions regarding this notification, contact Smiths Medical Customer Service Department at 1-866-831-8399.
Quantity in commerce: 13,696,830 units
Distribution: US: ALL STATES IN CONTINENTAL USA INCLUDING DC AND PR EXCEPT DE. OUS: UNITED ARAB EMIRATES, AUSTRIA BELGIUM, CANADA, CHINA, GERMANY, DENMARK, SPAIN, FINLAND, FRANCE, GREAT BRITAIN, HONG KONG, IRELAND, INDIA, ITALY, JAPAN, LUXEMBOURG, MAURITIUS, NEW CALEDONIA, NEW ZEALAND, PANAMA, PORTUGAL, SAUDI ARABIA, SWEDEN, SINGAPORE, TAIWAN, VIET NAAM, SOUTH AFRICA.
Product codes and lots: Devices with an expiration date on or before March 2021

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1831-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1831-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-08	2016-05-27

Product code FPA

K040636Class IICadd Administration Set with Flow Stop, Medication Cassette Reservoir with Flow Stop and Extension SetSmiths Medical MD, Inc. / cleared 2004-05-19

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)